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Braden Kuo - One of the best experts on this subject based on the ideXlab platform.

  • constipation in patients with symptoms of gastroparesis analysis of symptoms and gastrointestinal transit
    Clinical Gastroenterology and Hepatology, 2020
    Co-Authors: Henry P. Parkman, Braden Kuo, Richard W. Mccallum, William L. Hasler, Irene Sarosiek, Kenneth L. Koch, Thomas L Abell, Emily Sharkey, Robert J Shulman, Madhusudan Grover
    Abstract:

    Background & Aims Constipation can be an important symptom in some patients with gastroparesis. The aims were to: 1) Determine prevalence of constipation and delayed colonic transit in patients with symptoms of gastroparesis; 2) Correlate severity of constipation to severity of symptoms of gastroparesis; and 3) Relate severity of constipation to GI transit delays assessed by gastric emptying scintigraphy (GES) and wireless Motility Capsule (WMC). Methods Patients with symptoms of gastroparesis underwent gastric emptying scintigraphy (GES), wireless Motility Capsule (WMC) assessing gastric emptying, small bowel transit, and colonic transit, and questionnaires assessing symptoms using a modified Patient Assessment of Upper GI Symptoms [PAGI-SYM] and Rome III functional GI disorder questionnaire. Results Of 338 patients with symptoms of gastroparesis, 242 (71.5%) had delayed gastric emptying by scintigraphy; 298 (88.2%) also met criteria for functional dyspepsia. Severity of constipation was severe/very severe in 34% patients, moderate in 24%, and none/very mild/mild in 42%. Increasing severity of constipation was associated with increasing symptoms of gastroparesis and presence of irritable bowel syndrome (IBS). Severity of constipation was not associated with gastric retention on GES or WMC. Delayed colonic transit was present in 108 patients (32% of patients). Increasing severity of constipation was associated with increasing small bowel transit time, colonic transit time, and whole gut transit time. Conclusions Severe/very severe constipation and delayed colon transit occurs in a third of patients with symptoms of gastroparesis. The severity of constipation is associated with severity of gastroparesis symptoms, presence of IBS, small bowel and colon transit delay, but not delay in gastric emptying. ClinicalTrials.gov Identifier: NCT01696747

  • csp01 a novel superabsorbent hydrogel reduces colonic transit time in patients with chronic idiopathic constipation in a randomized double blind controlled pilot clinical trial
    Journal of Neurogastroenterology and Motility, 2020
    Co-Authors: Kyle Staller, Kenneth Barshop, Christopher D Velez, Abbey Bailey, Joseph J Locascio, Elaine Chiquette, Braden Kuo
    Abstract:

    Background/Aims CSP01 is a novel superabsorbent hydrogel that absorbs gastrointestinal fluids and maintains high viscoelastic properties into the colon, where these fluids are released. Methods We conducted a single-center, randomized, double-blind, parallel-group, placebo-controlled pilot study comparing change in colonic transit time (CTT) among patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) treated for 21 days with either CSP01 hydrogel, active control (carboxymethylcellulose [CMC]) or placebo. CTT was measured using wireless Motility Capsule transit testing at pre-treatment and end-of-treatment. The primary endpoint was change in CTT. Results Forty subjects (20 CSP01, 11 CMC, 9 placebo) were enrolled and 38 completed the study. There was no significant change in mean CTT by treatment group (P = 0.297). In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01. In post hoc analyses among those with CIC, mean CTT decreased by 1079 minutes for CSP01 (P = 0.025 compared to placebo), 919 minutes for CMC (P = 0.117 compared to placebo) and increased by 1113 minutes for placebo. Among patients with IBS-C, there was no significant difference in change in CTT for any treatment group. One subject in the CSP01 arm developed back pain attributed to constipation and withdrew without a second CTT measurement; there were no other adverse events. Conclusion CSP01 significantly decreased CTT compared to placebo among patients with CIC, but not in patients with IBS-C.

  • abdominal pain in patients with gastroparesis associations with gastroparesis symptoms etiology of gastroparesis gastric emptying somatization and quality of life
    Digestive Diseases and Sciences, 2019
    Co-Authors: Henry P. Parkman, Braden Kuo, Richard W. Mccallum, William L. Hasler, Irene Sarosiek, Kenneth L. Koch, Laura Wilson, Thomas L Abell, Ron Schey, William J Snape
    Abstract:

    Abdominal pain can be an important symptom in some patients with gastroparesis (Gp). (1) To describe characteristics of abdominal pain in Gp; (2) describe Gp patients reporting abdominal pain. Patients with idiopathic gastroparesis (IG) and diabetic gastroparesis (DG) were studied with gastric emptying scintigraphy, water load test, wireless Motility Capsule, and questionnaires assessing symptoms [Patient Assessment of Upper GI Symptoms (PAGI-SYM) including Gastroparesis Cardinal Symptom Index (GCSI)], quality of life (PAGI-QOL, SF-36), psychological state [Beck Depression Inventory (BDI), State-Trait Anxiety Index (STAI), PHQ-15 somatization scale]. In total, 346 Gp patients included 212 IG and 134 DG. Ninety percentage of Gp patients reported abdominal pain (89% DG and 91% IG). Pain was primarily in upper or central midline abdomen, described as cramping or sickening. Upper abdominal pain was severe or very severe on PAGI-SYM by 116/346 (34%) patients, more often by females than by males, but similarly in IG and DG. Increased upper abdominal pain severity was associated with increased severity of the nine GCSI symptoms, depression on BDI, anxiety on STAI, somatization on PHQ-15, the use of opiate medications, decreased SF-36 physical component, and PAGI-QOL, but not related to severity of delayed gastric emptying or water load ingestion. Using logistic regression, severe/very severe upper abdominal pain associated with increased GCSI scores, opiate medication use, and PHQ-15 somatic symptom scores. Abdominal pain is common in patients with Gp, both IG and DG. Severe/very severe upper abdominal pain occurred in 34% of Gp patients and associated with other Gp symptoms, somatization, and opiate medication use. ClinicalTrials.gov Identifier: NCT01696747.

  • colonic motor response to wakening is blunted in slow transit constipation as detected by wireless Motility Capsule
    Clinical and translational gastroenterology, 2018
    Co-Authors: Brian Surjanhata, Jack Semler, Kenneth Barshop, Kyle Staller, Laurence Guay, Braden Kuo
    Abstract:

    BACKGROUND Chronic constipation may be categorized as normal transit (NTC), slow transit (STC), or outlet obstruction. Colonic wake response is a relative increase in colonic Motility upon awakening. Colonic manometry studies have demonstrated attenuated wake response in STC. We sought to evaluate wake response among healthy (H), NTC, and STC patients using wireless Motility Capsule (WMC). METHODS A retrospective study of WMC data from a multicenter clinical trial and a tertiary gastroenterology clinic was performed. WMC Motility parameters of contraction frequency (Ct) and area under the contraction curve (AUC) were analyzed in 20-min windows 1-h before and after awakening. T-tests compared parameters between H, NTC, and STC. Linear regression analysis was performed to determine if outlet obstruction confounded data. A receiver operating characteristic curve demonstrated optimal Ct cut-offs to define blunted wake response. RESULTS A total of 62 H, 53 NTC and 75 STC subjects were analyzed. At 20, 40, and 60 min after awakening, STC subjects had significantly lower mean Ct when compared to H (p < 0.001) and NTC (p < 0.01). Linear regression demonstrated that outlet obstruction was not associated with a decreased wake response (β = 3.94, (CI -3.12-1.00), P = 0.27). Defined at the Ct threshold of 64 at 20-min post-wake, blunted wake response sensitivity was 84% and specificity was 32% for chronic constipation. CONCLUSION Findings of an impaired wake response in subjects with STC and not NTC adds further evidence to neuronal dysfunction as an etiology of STC, and identifies a possible temporal target for pharmacologic intervention.

  • duodenal rather than antral Motility contractile parameters correlate with symptom severity in gastroparesis patients
    Neurogastroenterology and Motility, 2015
    Co-Authors: Kenneth Barshop, Jack Semler, Kyle Staller, Braden Kuo
    Abstract:

    Background Studies of symptomatic gastroparetics consistently find poor correlation with gastric emptying. We hypothesized that concomitant small bowel dysMotility may play a role in symptom causation in gastroparesis and sought to test this hypothesis by using wireless Motility Capsule (WMC) testing to simultaneously measure antral and duodenal area under pressure curve (AUC) in patients with delayed gastric emptying.

William L. Hasler - One of the best experts on this subject based on the ideXlab platform.

  • constipation in patients with symptoms of gastroparesis analysis of symptoms and gastrointestinal transit
    Clinical Gastroenterology and Hepatology, 2020
    Co-Authors: Henry P. Parkman, Braden Kuo, Richard W. Mccallum, William L. Hasler, Irene Sarosiek, Kenneth L. Koch, Thomas L Abell, Emily Sharkey, Robert J Shulman, Madhusudan Grover
    Abstract:

    Background & Aims Constipation can be an important symptom in some patients with gastroparesis. The aims were to: 1) Determine prevalence of constipation and delayed colonic transit in patients with symptoms of gastroparesis; 2) Correlate severity of constipation to severity of symptoms of gastroparesis; and 3) Relate severity of constipation to GI transit delays assessed by gastric emptying scintigraphy (GES) and wireless Motility Capsule (WMC). Methods Patients with symptoms of gastroparesis underwent gastric emptying scintigraphy (GES), wireless Motility Capsule (WMC) assessing gastric emptying, small bowel transit, and colonic transit, and questionnaires assessing symptoms using a modified Patient Assessment of Upper GI Symptoms [PAGI-SYM] and Rome III functional GI disorder questionnaire. Results Of 338 patients with symptoms of gastroparesis, 242 (71.5%) had delayed gastric emptying by scintigraphy; 298 (88.2%) also met criteria for functional dyspepsia. Severity of constipation was severe/very severe in 34% patients, moderate in 24%, and none/very mild/mild in 42%. Increasing severity of constipation was associated with increasing symptoms of gastroparesis and presence of irritable bowel syndrome (IBS). Severity of constipation was not associated with gastric retention on GES or WMC. Delayed colonic transit was present in 108 patients (32% of patients). Increasing severity of constipation was associated with increasing small bowel transit time, colonic transit time, and whole gut transit time. Conclusions Severe/very severe constipation and delayed colon transit occurs in a third of patients with symptoms of gastroparesis. The severity of constipation is associated with severity of gastroparesis symptoms, presence of IBS, small bowel and colon transit delay, but not delay in gastric emptying. ClinicalTrials.gov Identifier: NCT01696747

  • validation of diagnostic and performance characteristics of the wireless Motility Capsule in patients with suspected gastroparesis
    Clinical Gastroenterology and Hepatology, 2019
    Co-Authors: Allen Lee, Satish S C Rao, Henry P. Parkman, Richard W. Mccallum, Irene Sarosiek, Gregory E Wilding, Linda Nguyen, Baharak Moshiree, Michael I Schulman, William L. Hasler
    Abstract:

    Background & Aims It is a challenge to make a diagnosis of gastroparesis. There is good agreement in results from wireless Motility Capsule (WMC) analysis and gastric emptying scintigraphy (GES), but the diagnostic yield of WMC is unclear and the accuracy of this method has not been validated. We compared the performance characteristics of WMC vs GES in assessing gastric emptying in patients with suspected gastroparesis. Methods We performed a prospective study of 167 subjects with gastroparesis (53 with diabetes and 114 without) at 10 centers, from 2013 through 2016. Subjects were assessed simultaneously by GES and with a WMC to measure gastric emptying and regional transit. Delayed gastric emptying by GES was defined as more than 10% meal retention at 4 hrs whereas delayed gastric emptying by WMC was defined as more than 5 hrs for passage of the Capsule into the duodenum; a severe delay in gastric emptying was defined as a gastric emptying time of more than 12 hrs by WMC or more than 35% retention at 4 hrs by GES. Rapid gastric emptying was defined as less than 38% meal retention at 1 hr based on by GES or gastric emptying times less than 1:45 hrs by WMC. We compared diagnostic and performance characteristics of GES vs WMC. Results Delayed gastric emptying was detected in a higher proportion of subjects by WMC (34.6%) than by GES (24.5%) (P=.009). Overall agreement in results between methods was 75.7% (kappa=0.42). In subjects without diabetes, the WMC detected a higher proportion of subjects with delayed gastric emptying (33.3%) than GES (17.1%) (P Conclusion Although there is agreement in analysis of gastric emptying by GES vs WMC, WMC provides higher diagnostic yield than GES. WMC detects delayed gastric emptying more frequently than GES and identifies extra-gastric transit abnormalities. Diabetic vs non-diabetic subjects have different results from GES vs WMC. These findings could affect management of patients with suspected gastroparesis. ClinicalTrials.gov no: NCT02022826 .

  • abdominal pain in patients with gastroparesis associations with gastroparesis symptoms etiology of gastroparesis gastric emptying somatization and quality of life
    Digestive Diseases and Sciences, 2019
    Co-Authors: Henry P. Parkman, Braden Kuo, Richard W. Mccallum, William L. Hasler, Irene Sarosiek, Kenneth L. Koch, Laura Wilson, Thomas L Abell, Ron Schey, William J Snape
    Abstract:

    Abdominal pain can be an important symptom in some patients with gastroparesis (Gp). (1) To describe characteristics of abdominal pain in Gp; (2) describe Gp patients reporting abdominal pain. Patients with idiopathic gastroparesis (IG) and diabetic gastroparesis (DG) were studied with gastric emptying scintigraphy, water load test, wireless Motility Capsule, and questionnaires assessing symptoms [Patient Assessment of Upper GI Symptoms (PAGI-SYM) including Gastroparesis Cardinal Symptom Index (GCSI)], quality of life (PAGI-QOL, SF-36), psychological state [Beck Depression Inventory (BDI), State-Trait Anxiety Index (STAI), PHQ-15 somatization scale]. In total, 346 Gp patients included 212 IG and 134 DG. Ninety percentage of Gp patients reported abdominal pain (89% DG and 91% IG). Pain was primarily in upper or central midline abdomen, described as cramping or sickening. Upper abdominal pain was severe or very severe on PAGI-SYM by 116/346 (34%) patients, more often by females than by males, but similarly in IG and DG. Increased upper abdominal pain severity was associated with increased severity of the nine GCSI symptoms, depression on BDI, anxiety on STAI, somatization on PHQ-15, the use of opiate medications, decreased SF-36 physical component, and PAGI-QOL, but not related to severity of delayed gastric emptying or water load ingestion. Using logistic regression, severe/very severe upper abdominal pain associated with increased GCSI scores, opiate medication use, and PHQ-15 somatic symptom scores. Abdominal pain is common in patients with Gp, both IG and DG. Severe/very severe upper abdominal pain occurred in 34% of Gp patients and associated with other Gp symptoms, somatization, and opiate medication use. ClinicalTrials.gov Identifier: NCT01696747.

  • relating gastric scintigraphy and symptoms to Motility Capsule transit and pressure findings in suspected gastroparesis
    Neurogastroenterology and Motility, 2018
    Co-Authors: William L. Hasler, Henry P. Parkman, Richard W. Mccallum, Pankaj J. Pasricha, Thomas L Abell, Kevin P May, L A Wilson, M L Van Natta, K L Koch, Linda Anh B Nguyen
    Abstract:

    Background Wireless Motility Capsule (WMC) findings are incompletely defined in suspected gastroparesis. We aimed to characterize regional WMC transit and contractility in relation to scintigraphy, etiology, and symptoms in patients undergoing gastric emptying testing. Methods A total of 209 patients with gastroparesis symptoms at NIDDK Gastroparesis Consortium centers underwent gastric scintigraphy and WMCs on separate days to measure regional transit and contractility. Validated questionnaires quantified symptoms. Key Results Solid scintigraphy and liquid scintigraphy were delayed in 68.8% and 34.8% of patients; WMC gastric emptying times (GET) were delayed in 40.3% and showed 52.8% agreement with scintigraphy; 15.5% and 33.5% had delayed small bowel (SBTT) and colon transit (CTT) times. Transit was delayed in ≥2 regions in 23.3%. Rapid transit was rarely observed. Diabetics had slower GET but more rapid SBTT versus idiopathics (P ≤ .02). GET delays related to greater scintigraphic retention, slower SBTT, and fewer gastric contractions (P ≤ .04). Overall gastroparesis symptoms and nausea/vomiting, early satiety/fullness, bloating/distention, and upper abdominal pain subscores showed no relation to WMC transit. Upper and lower abdominal pain scores (P ≤ .03) were greater with increased colon contractions. Constipation correlated with slower CTT and higher colon contractions (P = .03). Diarrhea scores were higher with delayed SBTT and CTT (P ≤ .04). Conclusions & Inferences Wireless Motility Capsules define gastric emptying delays similar but not identical to scintigraphy that are more severe in diabetics and relate to reduced gastric contractility. Extragastric transit delays occur in >40% with suspected gastroparesis. Gastroparesis symptoms show little association with WMC profiles, although lower symptoms relate to small bowel or colon abnormalities.

  • regional gastrointestinal contractility parameters using the wireless Motility Capsule inter observer reproducibility and influence of age gender and study country
    Alimentary Pharmacology & Therapeutics, 2018
    Co-Authors: Adam D Farmer, John R. Semler, Annemarie Langmach Wegeberg, Birgitte Brock, A R Hobson, S D Mohammed, Stephen Scott, Caroline Brucknerholt, William L. Hasler
    Abstract:

    Aalborg University, Novo Nordisk Foundation and the Research and Development Department, Uppsala University

John R. Semler - One of the best experts on this subject based on the ideXlab platform.

  • comparison of ph and Motility of the small intestine of healthy subjects and patients with symptomatic constipation using the wireless Motility Capsule
    International Journal of Pharmaceutics, 2018
    Co-Authors: Aktham Aburub, John R. Semler, Michael Camilleri, Monika Fischer, Hala M Fadda
    Abstract:

    Abstract Gastrointestinal luminal pH shows a rise from the duodenum to the terminal ileum in healthy individuals. Our objectives were to compare the pH in the proximal small intestine (SI) (first 60 min of small intestinal transit) lumen of human volunteers and patients with symptomatic constipation; to quantify contractile pressure profiles of the proximal SI, and to assess the relationship between luminally-recorded contractile pressure and small intestinal transit times (SITT) of a non-disintegrating Capsule that measures pH and pressure activity (wireless Motility Capsule). We used previously acquired records from 39 healthy subjects and 41 patients with symptomatic constipation. Mean pH (±SD) of the proximal SI was similar in healthy subjects and patients with constipation at 6.2 (±0.6) and 6.3 (±0.4), respectively. In 13 of the healthy subjects, pH did not rise uniformly in the proximal SI though the pHmedian was 6.0 (5th, 95th percentiles 3.09, 7.06) and the pH fluctuated over a mean period of 28 min. Large inter-individual variability in frequency of pressure activity (Ct) and area under pressure curve (AUC) were observed in the proximal SI of healthy subjects and patients with constipation. Median AUC was 3996 mmHg s−1 (5th, 95th percentiles 948, 16866 mmHg s−1) in these two populations combined. Ct and AUC showed a strong direct linear correlation at r = 0.91, p

  • small bowel fed response as measured by wireless Motility Capsule comparative analysis in healthy gastroparetic and constipated subjects
    Neurogastroenterology and Motility, 2018
    Co-Authors: Brian Surjanhata, John R. Semler, R Brun, G Wilding, B Kuo
    Abstract:

    BACKGROUND Small bowel fed response is an increased contractile activity pattern following the ingestion of a meal. Postprandial Motility is traditionally evaluated using small bowel manometry. Wireless Motility Capsule (WMC) is an ingestible wireless Capsule that measures pH, temperature, and intraluminal pressure. The primary aim of the study was to assess small bowel fed response captured with the non-invasive WMC. The secondary aim was to compare the fed response patterns between healthy subjects and patients with Motility disorders of gastroparesis and constipation. METHODS All subjects had 250 cc Ensure® meal 6 hours after WMC ingestion. Frequency of contractions (Ct), area under the curve (AUC), and Motility index (MI) were analyzed during 30 minutes of pre-prandial baseline and 60 minutes postprandially in 20-minute windows. KEY RESULTS One hundred and eighty-eight subjects (107 healthy, 23 gastroparetics, 58 constipated) were analyzed. Healthy: Ct, AUC, and MI all increased significantly immediately after meal ingestion (P < .01). Motility parameters peak at 20-40 minutes postmeal. The motor activity decreased at the end of postprandial hour, but was still significantly higher than the fasting baseline (P < .01). Gastroparetics: All Motility parameters failed to increase significantly compared to the baseline throughout the entire postprandial hour. Constipated: The fed response was similar to healthy subjects. CONCLUSIONS AND INFERENCES The small bowel fed response was readily observed in healthy and chronic constipation subjects with WMC but is blunted in gastroparetics. A blunted small bowel fed response suggests neuropathic changes outside the stomach and may contribute to postprandial symptoms.

  • regional gastrointestinal contractility parameters using the wireless Motility Capsule inter observer reproducibility and influence of age gender and study country
    Alimentary Pharmacology & Therapeutics, 2018
    Co-Authors: Adam D Farmer, John R. Semler, Annemarie Langmach Wegeberg, Birgitte Brock, A R Hobson, S D Mohammed, Stephen Scott, Caroline Brucknerholt, William L. Hasler
    Abstract:

    Aalborg University, Novo Nordisk Foundation and the Research and Development Department, Uppsala University

  • normative values of regional and sub regional gastrointestinal Motility and contractility parameters using the wireless Motility Capsule
    Neurogastroenterology and Motility, 2017
    Co-Authors: Annemarie Langmach Wegeberg, John R. Semler, Birgitte Brock, A R Hobson, S D Mohammed, Stephen Scott, D Richards, Per M Hellstrom, Asbjorn Mohr Drewes, Christina Brock
    Abstract:

    Normative values of regional and sub-regional gastrointestinal Motility and contractility parameters using the wireless Motility Capsule

  • blunting of colon contractions in diabetics with gastroparesis quantified by wireless Motility Capsule methods
    PLOS ONE, 2015
    Co-Authors: Radoslav Coleski, John R. Semler, Gregory E Wilding, William L. Hasler
    Abstract:

    Generalized gut transit abnormalities are observed in some diabetics with gastroparesis. Relations of gastric emptying abnormalities to colon contractile dysfunction are poorly characterized. We measured colon transit and contractility using wireless Motility Capsules (WMC) in 41 healthy subjects, 12 diabetics with gastroparesis (defined by gastric retention >5 hours), and 8 diabetics with normal gastric emptying (≤5 hours). Overall numbers of colon contractions >25 mmHg were calculated in all subjects and were correlated with gastric emptying times for diabetics with gastroparesis. Colon transit periods were divided into quartiles by time and contraction numbers were calculated for each quartile to estimate regional colon contractility. Colon transit in diabetics with gastroparesis was prolonged vs. healthy subjects (P<0.0001). Overall numbers of colon contractions in gastroparetics were lower than controls (P = 0.02). Diabetics with normal emptying showed transit and contraction numbers similar to controls. Gastric emptying inversely correlated with overall contraction numbers in gastroparetics (r = -0.49). Numbers of contractions increased from the 1st to 4th colon transit quartile in controls and diabetics with normal emptying (P≤0.04), but not gastroparetics. Numbers of contractions in the 3rd and 4th quartiles were reduced in gastroparetics vs. healthy controls (P≤0.05) and in the 4th quartile vs. diabetics with normal emptying (P = 0.02). Numbers of contractions were greatest in the final 15 minutes of transit, but were reduced in gastroparetics vs. healthy controls and diabetics with normal emptying (P≤0.005). On multivariate analyses, differences in numbers of contractions were not explained by demographic or clinical variables. In conclusion, diabetics with gastroparesis exhibit delayed colon transit associated with reductions in contractions that are prominently blunted in latter transit phases and which correlate with delayed gastric emptying, while diabetics with normal emptying show no significant colonic impairments. These findings emphasize diabetic gastroparesis may be part of a generalized dysMotility syndrome.

Richard W. Mccallum - One of the best experts on this subject based on the ideXlab platform.

  • constipation in patients with symptoms of gastroparesis analysis of symptoms and gastrointestinal transit
    Clinical Gastroenterology and Hepatology, 2020
    Co-Authors: Henry P. Parkman, Braden Kuo, Richard W. Mccallum, William L. Hasler, Irene Sarosiek, Kenneth L. Koch, Thomas L Abell, Emily Sharkey, Robert J Shulman, Madhusudan Grover
    Abstract:

    Background & Aims Constipation can be an important symptom in some patients with gastroparesis. The aims were to: 1) Determine prevalence of constipation and delayed colonic transit in patients with symptoms of gastroparesis; 2) Correlate severity of constipation to severity of symptoms of gastroparesis; and 3) Relate severity of constipation to GI transit delays assessed by gastric emptying scintigraphy (GES) and wireless Motility Capsule (WMC). Methods Patients with symptoms of gastroparesis underwent gastric emptying scintigraphy (GES), wireless Motility Capsule (WMC) assessing gastric emptying, small bowel transit, and colonic transit, and questionnaires assessing symptoms using a modified Patient Assessment of Upper GI Symptoms [PAGI-SYM] and Rome III functional GI disorder questionnaire. Results Of 338 patients with symptoms of gastroparesis, 242 (71.5%) had delayed gastric emptying by scintigraphy; 298 (88.2%) also met criteria for functional dyspepsia. Severity of constipation was severe/very severe in 34% patients, moderate in 24%, and none/very mild/mild in 42%. Increasing severity of constipation was associated with increasing symptoms of gastroparesis and presence of irritable bowel syndrome (IBS). Severity of constipation was not associated with gastric retention on GES or WMC. Delayed colonic transit was present in 108 patients (32% of patients). Increasing severity of constipation was associated with increasing small bowel transit time, colonic transit time, and whole gut transit time. Conclusions Severe/very severe constipation and delayed colon transit occurs in a third of patients with symptoms of gastroparesis. The severity of constipation is associated with severity of gastroparesis symptoms, presence of IBS, small bowel and colon transit delay, but not delay in gastric emptying. ClinicalTrials.gov Identifier: NCT01696747

  • baseline predictors of longitudinal changes in symptom severity and quality of life in patients with suspected gastroparesis
    Clinical Gastroenterology and Hepatology, 2020
    Co-Authors: Henry P. Parkman, Richard W. Mccallum, Irene Sarosiek, Allen Lee, Linda Nguyen, Baharak Moshiree, Michael I Schulman, Krishna Rao, Satish S C Rao
    Abstract:

    ABSTRACT Background and Aims Whether gastric emptying tests predict longitudinal outcomes in patients with symptoms of gastroparesis is unclear. We aimed to determine whether baseline gastric emptying tests and gut Motility parameters could impact longitudinal symptom(s) and quality of life (QOL) in a prospective, observational cohort study of patients with symptoms of gastroparesis. Methods One hundred fifty patients with gastroparesis symptoms underwent simultaneous scintigraphy (GES) and wireless Motility Capsule (WMC) measurement of gastric emptying and other Motility parameters. Patient Assessment of Upper Gastrointestinal Symptoms and Quality of Life were administered at baseline, and 3 and 6 months after testing. Multivariable generalized linear marginal models were fit to determine which baseline parameters predict longitudinal changes in symptoms and QOL. Results Overall upper GI symptoms and QOL scores were moderate in severity at baseline and significantly improved over 6 months. Clinical variables, including female gender, harder stools by Bristol stool form score, and presence of functional dyspepsia (FD) by Rome III criteria, were predictive of more severe upper GI symptoms. Even after controlling for these clinical factors, delayed gastric emptying by GES or WMC was associated with worse symptom severity and QOL scores. Low gastric and elevated small bowel contractile parameters by WMC were also independently associated with more severe upper GI symptoms and worse QOL scores. Conclusions Baseline features, including demographic and clinical variables, delayed gastric emptying and abnormal gastrointestinal contractility, were independent predictors of more severe longitudinal symptoms and worse quality of life outcomes. These factors may help to risk stratify patients and guide treatment decisions. ClinicalTrials.gov no: NCT02022826.

  • validation of diagnostic and performance characteristics of the wireless Motility Capsule in patients with suspected gastroparesis
    Clinical Gastroenterology and Hepatology, 2019
    Co-Authors: Allen Lee, Satish S C Rao, Henry P. Parkman, Richard W. Mccallum, Irene Sarosiek, Gregory E Wilding, Linda Nguyen, Baharak Moshiree, Michael I Schulman, William L. Hasler
    Abstract:

    Background & Aims It is a challenge to make a diagnosis of gastroparesis. There is good agreement in results from wireless Motility Capsule (WMC) analysis and gastric emptying scintigraphy (GES), but the diagnostic yield of WMC is unclear and the accuracy of this method has not been validated. We compared the performance characteristics of WMC vs GES in assessing gastric emptying in patients with suspected gastroparesis. Methods We performed a prospective study of 167 subjects with gastroparesis (53 with diabetes and 114 without) at 10 centers, from 2013 through 2016. Subjects were assessed simultaneously by GES and with a WMC to measure gastric emptying and regional transit. Delayed gastric emptying by GES was defined as more than 10% meal retention at 4 hrs whereas delayed gastric emptying by WMC was defined as more than 5 hrs for passage of the Capsule into the duodenum; a severe delay in gastric emptying was defined as a gastric emptying time of more than 12 hrs by WMC or more than 35% retention at 4 hrs by GES. Rapid gastric emptying was defined as less than 38% meal retention at 1 hr based on by GES or gastric emptying times less than 1:45 hrs by WMC. We compared diagnostic and performance characteristics of GES vs WMC. Results Delayed gastric emptying was detected in a higher proportion of subjects by WMC (34.6%) than by GES (24.5%) (P=.009). Overall agreement in results between methods was 75.7% (kappa=0.42). In subjects without diabetes, the WMC detected a higher proportion of subjects with delayed gastric emptying (33.3%) than GES (17.1%) (P Conclusion Although there is agreement in analysis of gastric emptying by GES vs WMC, WMC provides higher diagnostic yield than GES. WMC detects delayed gastric emptying more frequently than GES and identifies extra-gastric transit abnormalities. Diabetic vs non-diabetic subjects have different results from GES vs WMC. These findings could affect management of patients with suspected gastroparesis. ClinicalTrials.gov no: NCT02022826 .

  • abdominal pain in patients with gastroparesis associations with gastroparesis symptoms etiology of gastroparesis gastric emptying somatization and quality of life
    Digestive Diseases and Sciences, 2019
    Co-Authors: Henry P. Parkman, Braden Kuo, Richard W. Mccallum, William L. Hasler, Irene Sarosiek, Kenneth L. Koch, Laura Wilson, Thomas L Abell, Ron Schey, William J Snape
    Abstract:

    Abdominal pain can be an important symptom in some patients with gastroparesis (Gp). (1) To describe characteristics of abdominal pain in Gp; (2) describe Gp patients reporting abdominal pain. Patients with idiopathic gastroparesis (IG) and diabetic gastroparesis (DG) were studied with gastric emptying scintigraphy, water load test, wireless Motility Capsule, and questionnaires assessing symptoms [Patient Assessment of Upper GI Symptoms (PAGI-SYM) including Gastroparesis Cardinal Symptom Index (GCSI)], quality of life (PAGI-QOL, SF-36), psychological state [Beck Depression Inventory (BDI), State-Trait Anxiety Index (STAI), PHQ-15 somatization scale]. In total, 346 Gp patients included 212 IG and 134 DG. Ninety percentage of Gp patients reported abdominal pain (89% DG and 91% IG). Pain was primarily in upper or central midline abdomen, described as cramping or sickening. Upper abdominal pain was severe or very severe on PAGI-SYM by 116/346 (34%) patients, more often by females than by males, but similarly in IG and DG. Increased upper abdominal pain severity was associated with increased severity of the nine GCSI symptoms, depression on BDI, anxiety on STAI, somatization on PHQ-15, the use of opiate medications, decreased SF-36 physical component, and PAGI-QOL, but not related to severity of delayed gastric emptying or water load ingestion. Using logistic regression, severe/very severe upper abdominal pain associated with increased GCSI scores, opiate medication use, and PHQ-15 somatic symptom scores. Abdominal pain is common in patients with Gp, both IG and DG. Severe/very severe upper abdominal pain occurred in 34% of Gp patients and associated with other Gp symptoms, somatization, and opiate medication use. ClinicalTrials.gov Identifier: NCT01696747.

  • relating gastric scintigraphy and symptoms to Motility Capsule transit and pressure findings in suspected gastroparesis
    Neurogastroenterology and Motility, 2018
    Co-Authors: William L. Hasler, Henry P. Parkman, Richard W. Mccallum, Pankaj J. Pasricha, Thomas L Abell, Kevin P May, L A Wilson, M L Van Natta, K L Koch, Linda Anh B Nguyen
    Abstract:

    Background Wireless Motility Capsule (WMC) findings are incompletely defined in suspected gastroparesis. We aimed to characterize regional WMC transit and contractility in relation to scintigraphy, etiology, and symptoms in patients undergoing gastric emptying testing. Methods A total of 209 patients with gastroparesis symptoms at NIDDK Gastroparesis Consortium centers underwent gastric scintigraphy and WMCs on separate days to measure regional transit and contractility. Validated questionnaires quantified symptoms. Key Results Solid scintigraphy and liquid scintigraphy were delayed in 68.8% and 34.8% of patients; WMC gastric emptying times (GET) were delayed in 40.3% and showed 52.8% agreement with scintigraphy; 15.5% and 33.5% had delayed small bowel (SBTT) and colon transit (CTT) times. Transit was delayed in ≥2 regions in 23.3%. Rapid transit was rarely observed. Diabetics had slower GET but more rapid SBTT versus idiopathics (P ≤ .02). GET delays related to greater scintigraphic retention, slower SBTT, and fewer gastric contractions (P ≤ .04). Overall gastroparesis symptoms and nausea/vomiting, early satiety/fullness, bloating/distention, and upper abdominal pain subscores showed no relation to WMC transit. Upper and lower abdominal pain scores (P ≤ .03) were greater with increased colon contractions. Constipation correlated with slower CTT and higher colon contractions (P = .03). Diarrhea scores were higher with delayed SBTT and CTT (P ≤ .04). Conclusions & Inferences Wireless Motility Capsules define gastric emptying delays similar but not identical to scintigraphy that are more severe in diabetics and relate to reduced gastric contractility. Extragastric transit delays occur in >40% with suspected gastroparesis. Gastroparesis symptoms show little association with WMC profiles, although lower symptoms relate to small bowel or colon abnormalities.

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  • baseline predictors of longitudinal changes in symptom severity and quality of life in patients with suspected gastroparesis
    Clinical Gastroenterology and Hepatology, 2020
    Co-Authors: Henry P. Parkman, Richard W. Mccallum, Irene Sarosiek, Allen Lee, Linda Nguyen, Baharak Moshiree, Michael I Schulman, Krishna Rao, Satish S C Rao
    Abstract:

    ABSTRACT Background and Aims Whether gastric emptying tests predict longitudinal outcomes in patients with symptoms of gastroparesis is unclear. We aimed to determine whether baseline gastric emptying tests and gut Motility parameters could impact longitudinal symptom(s) and quality of life (QOL) in a prospective, observational cohort study of patients with symptoms of gastroparesis. Methods One hundred fifty patients with gastroparesis symptoms underwent simultaneous scintigraphy (GES) and wireless Motility Capsule (WMC) measurement of gastric emptying and other Motility parameters. Patient Assessment of Upper Gastrointestinal Symptoms and Quality of Life were administered at baseline, and 3 and 6 months after testing. Multivariable generalized linear marginal models were fit to determine which baseline parameters predict longitudinal changes in symptoms and QOL. Results Overall upper GI symptoms and QOL scores were moderate in severity at baseline and significantly improved over 6 months. Clinical variables, including female gender, harder stools by Bristol stool form score, and presence of functional dyspepsia (FD) by Rome III criteria, were predictive of more severe upper GI symptoms. Even after controlling for these clinical factors, delayed gastric emptying by GES or WMC was associated with worse symptom severity and QOL scores. Low gastric and elevated small bowel contractile parameters by WMC were also independently associated with more severe upper GI symptoms and worse QOL scores. Conclusions Baseline features, including demographic and clinical variables, delayed gastric emptying and abnormal gastrointestinal contractility, were independent predictors of more severe longitudinal symptoms and worse quality of life outcomes. These factors may help to risk stratify patients and guide treatment decisions. ClinicalTrials.gov no: NCT02022826.

  • validation of diagnostic and performance characteristics of the wireless Motility Capsule in patients with suspected gastroparesis
    Clinical Gastroenterology and Hepatology, 2019
    Co-Authors: Allen Lee, Satish S C Rao, Henry P. Parkman, Richard W. Mccallum, Irene Sarosiek, Gregory E Wilding, Linda Nguyen, Baharak Moshiree, Michael I Schulman, William L. Hasler
    Abstract:

    Background & Aims It is a challenge to make a diagnosis of gastroparesis. There is good agreement in results from wireless Motility Capsule (WMC) analysis and gastric emptying scintigraphy (GES), but the diagnostic yield of WMC is unclear and the accuracy of this method has not been validated. We compared the performance characteristics of WMC vs GES in assessing gastric emptying in patients with suspected gastroparesis. Methods We performed a prospective study of 167 subjects with gastroparesis (53 with diabetes and 114 without) at 10 centers, from 2013 through 2016. Subjects were assessed simultaneously by GES and with a WMC to measure gastric emptying and regional transit. Delayed gastric emptying by GES was defined as more than 10% meal retention at 4 hrs whereas delayed gastric emptying by WMC was defined as more than 5 hrs for passage of the Capsule into the duodenum; a severe delay in gastric emptying was defined as a gastric emptying time of more than 12 hrs by WMC or more than 35% retention at 4 hrs by GES. Rapid gastric emptying was defined as less than 38% meal retention at 1 hr based on by GES or gastric emptying times less than 1:45 hrs by WMC. We compared diagnostic and performance characteristics of GES vs WMC. Results Delayed gastric emptying was detected in a higher proportion of subjects by WMC (34.6%) than by GES (24.5%) (P=.009). Overall agreement in results between methods was 75.7% (kappa=0.42). In subjects without diabetes, the WMC detected a higher proportion of subjects with delayed gastric emptying (33.3%) than GES (17.1%) (P Conclusion Although there is agreement in analysis of gastric emptying by GES vs WMC, WMC provides higher diagnostic yield than GES. WMC detects delayed gastric emptying more frequently than GES and identifies extra-gastric transit abnormalities. Diabetic vs non-diabetic subjects have different results from GES vs WMC. These findings could affect management of patients with suspected gastroparesis. ClinicalTrials.gov no: NCT02022826 .

  • diagnosis and management of chronic constipation in adults
    Nature Reviews Gastroenterology & Hepatology, 2016
    Co-Authors: Satish S C Rao, Kulthep Rattanakovit, Tanisa Patcharatrakul
    Abstract:

    Constipation is a heterogeneous, polysymptomatic, multifactorial disease. Acute or transient constipation can be due to changes in diet, travel or stress, and secondary constipation can result from drug treatment, neurological or metabolic conditions or, rarely, colon cancer. A diagnosis of primary chronic constipation is made after exclusion of secondary causes of constipation and encompasses several overlapping subtypes. Slow-transit constipation is characterized by prolonged colonic transit in the absence of pelvic floor dysfunction. This subtype of constipation can be identified using either the radio-opaque marker test or wireless Motility Capsule test, and is best treated with laxatives such as polyethylene glycol or newer agents such as linaclotide or lubiprostone. If unsuccessful, subspecialist referral should be considered. Dyssynergic defecation results from impaired coordination of rectoanal and pelvic floor muscles, and causes difficulty with defecation. The condition can be identified using anorectal manometry and balloon expulsion tests and is best managed with biofeedback therapy. Opioid-induced constipation is an emerging entity, and several drugs including naloxegol, methylnaltrexone and lubiprostone are approved for its treatment. In this Review, we provide an overview of the burden and pathophysiology of chronic constipation, as well as a detailed discussion of the available diagnostic tools and treatment options.

  • Regional gastrointestinal transit and pH studied in 215 healthy volunteers using the wireless Motility Capsule: Influence of age, gender, study country and testing protocol
    Alimentary Pharmacology and Therapeutics, 2015
    Co-Authors: Y T Wang, Sahar D Mohammed, Natalia Zarate, Anthony R. Hobson, P. M. Hellstr??m, Braden Kuo, Adam D Farmer, John R. Semler, Satish S C Rao, Michael Camilleri, William L. Hasler, D. Wang, S. Mark Scott
    Abstract:

    BACKGROUND: The wireless Motility Capsule (WMC) offers the ability to investigate luminal gastrointestinal (GI) physiology in a minimally invasive manner.\n\nAIM: To investigate the effect of testing protocol, gender, age and study country on regional GI transit times and associated pH values using the WMC.\n\nMETHODS: Regional GI transit times and pH values were determined in 215 healthy volunteers from USA and Sweden studied using the WMC over a 6.5-year period. The effects of test protocol, gender, age and study country were examined.\n\nRESULTS: For GI transit times, testing protocol was associated with differences in gastric emptying time (GET; shorter with protocol 2 (Motility Capsule ingested immediately after meal) vs. protocol 1 (Motility Capsule immediately before): median difference: 52 min, P = 0.0063) and colonic transit time (CTT; longer with protocol 2: median 140 min, P = 0.0189), but had no overall effect on whole gut transit time. Females had longer GET (by median 17 min, P = 0.0307), and also longer CTT by (104 min, P = 0.0285) and whole gut transit time by (263 min, P = 0.0077). Increasing age was associated with shorter small bowel transit time (P = 0.002), and study country also influenced small bowel and CTTs. Whole gut and CTTs showed clustering of data at values separated by 24 h, suggesting that describing these measures as continuous variables is invalid. Testing protocol, gender and study country also significantly influenced pH values.\n\nCONCLUSIONS: Regional GI transit times and pH values, delineated using the wireless Motility Capsule (WMC), vary based on testing protocol, gender, age and country. Standardisation of testing is crucial for cross-referencing in clinical practice and future research.

  • How to assess regional and whole gut transit time with wireless Motility Capsule
    Journal of Neurogastroenterology and Motility, 2014
    Co-Authors: Yeong Yeh Lee, Askin Erdogan, Satish S C Rao
    Abstract:

    Assessment of transit through the gastrointestinal tract provides useful information regarding gut physiology and patho-physiology. Although several methods are available, each has distinct advantages and limitations. Recently, an ingestible wire-less Motility Capsule (WMC), similar to Capsule video endoscopy, has become available that offers a less-invasive, standardized, radiation-free and office-based test. The Capsule has 3 sensors for measurement of pH, pressure and temperature, and collec-tively the information provided by these sensors is used to measure gastric emptying time, small bowel transit time, colonic transit time and whole gut transit time. Current approved indications for the test include the evaluation of gastric emptying in gastroparesis, colonic transit in constipation and evaluation of generalised dysMotility. Rare Capsule retention and malfunc-tion are known limitations and some patients may experience difficulty with swallowing the Capsule. The use of WMC has been validated for the assessment of gastrointestinal transit. The normal range for transit time includes the following: gastric empty-ing (2-5 hours), small bowel transit (2-6 hours), colonic transit (10-59 hours) and whole gut transit (10-73 hours). Besides avoiding the use of multiple endoscopic, radiologic and functional gastrointestinal tests, WMC can provide new diagnoses, leads to a change in management decision and help to direct further focused work-ups in patients with suspected disordered Motility. In conclusion, WMC represents a significant advance in the assessment of segmental and whole gut transit and mo-tility, and could prove to be an indispensable diagnostic tool for gastrointestinal physicians worldwide.