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F Savino - One of the best experts on this subject based on the ideXlab platform.

  • Dietary modifications for Infantile Colic
    'Wiley', 2018
    Co-Authors: Morris Gordon, E. Biagioli, C. Lingua, L. Moja, Simone Ceratto, M. Sorrenti, S. Banks, F Savino
    Abstract:

    Background Infantile Colic is typically defined as full-force crying for at least three hours per day, on at least three days per week, for at least three weeks. This condition appears to be more frequent in the first six weeks of life (prevalence range of 17% to 25%), depending on the specific location reported and definitions used, and it usually resolves by three months of age. The aetiopathogenesis of Infantile Colic is unclear but most likely multifactorial. A number of psychological, behavioural and biological components (food hypersensitivity, allergy or both; gut microflora and dysmotility) are thought to contribute to its manifestation. The role of diet as a component in Infantile Colic remains controversial. Objectives To assess the effects of dietary modifications for reducing Colic in infants less than four months of age. Search methods In July 2018 we searched CENTRAL, MEDLINE, Embase, 17 other databases and 2 trials registers. We also searched Google, checked and handsearched references and contacted study authors. Selection criteria Randomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of dietary modifications, alone or in combination, for Colicky infants younger than four months of age versus another intervention or placebo. We used specific definitions for Colic, age of onset and the methods for performing the intervention. We defined 'modified diet' as any diet altered to include or exclude certain components. Data collection and analysis We used standard methodological procedures expected by Cochrane. Our primary outcome was duration of crying, and secondary outcomes were response to intervention, frequency of crying episodes, parental/family quality of life, infant sleep duration, parental satisfaction and adverse effects. Main results We included 15 RCTs involving 1121 infants (balanced numbers of boys and girls) aged 2 to 16 weeks. All studies were small and at high risk of bias across multiple design factors (e.g. selection, attrition). The studies covered a wide range of dietary interventions, and there was limited scope for meta-analysis. Using the GRADE approach, we assessed the quality of the evidence as very low. Low-allergen maternal diet versus a diet containing known potential allergens: one study (90 infants) found that 35/47 (74%) of infants responded to a low-allergen maternal diet, compared with 16/43 (37%) of infants on a diet containing known potential allergens. Low-allergen diet or soy milk formula versus dicyclomine hydrochloride: one study (120 infants) found that 10/15 (66.6%) breastfed babies responded to dicyclomine hydrochloride, compared with 24/45 (53.3%) formula-fed babies. There was little difference in response between breastfed babies whose mother changed their diet (10/16; 62.5%) and babies who received soy milk formula (29/44; 65.9%). Hydrolysed formula versus standard formula: two studies (64 infants) found no difference in duration of crying, reported as a dichotomous outcome: risk ratio 2.03, 95% confidence interval (CI) 0.81 to 5.10; very low-quality evidence. The author of one study confirmed there were no adverse effects. One study (43 infants) reported a greater reduction in crying time postintervention with hydrolysed formula (104 min/d, 95% CI 55 to 155) than with standard formula (3 min/d, 95% CI 63 to 67). Hydrolysed formula versus another hydrolysed formula: one study (22 infants) found that two types of hydrolysed formula were equally effective in resolving symptoms for babies who commenced with standard formula (Alimentum reduced crying to 2.21 h/d (standard deviation (SD) 0.40) and Nutramigen to 2.93 h/d (SD 0.70)). Hydrolysed formula or dairy- and soy-free maternal diet versus addition of parental education or counselling: one study (21 infants) found that crying time decreased to 2.03 h/d (SD 1.03) in the hydrolysed or dairy- and soy-free group compared with 1.08 h/d (SD 0.7) in the parent education or counselling group, nine days into the intervention. Partially hydrolysed, lower lactose, whey-based formulae containing oligosaccharide versus standard formula with sitnethicone: one study (267 infants) found that both groups experienced a decrease in Colic episodes (secondary outcome) after seven days (partially hydrolysed formula: from 5.99 episodes (SD 1.84) to 2.47 episodes (SD 1.94); standard formula: from 5.41 episodes (SD 1.88) to 3.72 episodes (SD 1.98)). After two weeks the difference between the two groups was significant (partially hydrolysed: 1.76 episodes (SD 1.60); standard formula: 3.32 episodes (SD 2.06)). The study author confirmed there were no adverse effects. Lactase enzyme supplementation versus placebo: three studies (138 infants) assessed this comparison, but none reported data amenable to analysis for any outcome. There were no adverse effects in any of the studies. Extract of Foeniculum vulgare, Matricariae recutita, and Melissa officinalis versus placebo: one study (93 infants) found that average daily crying time was lower for infants given the extract (76.9 min/d (SD 23.5), than infants given placebo (169.9 min/d (SD 23.1), at the end of the one-week study. There were no adverse effects. Soy protein-based formula versus standard cows' milk protein-based formula: one study (19 infants) reported a mean crying time of 12.7 h/week (SD 16.4) in the soy formula group versus 17.3 h/week (SD 6.9) in the standard cows' milk group, and that 5/10 (50%) responded in the soy formula group versus 0/9 (0%) in the standard cows' milk group. Soy protein formula with polysaccharide versus standard soy protein formula: one study (27 infants) assessed this comparison but did not provide disaggregated data for the number of responders in each group after treatment. No study reported on our secondary outcomes of parental or family quality of life, infant sleep duration per 24 h, or parental satisfaction. Authors' conclusions Currently, evidence of the effectiveness of dietary modifications for the treatment of Infantile Colic is sparse and at significant risk of bias. The few available studies had small sample sizes, and most had serious limitations. There were insufficient studies, thus limiting the use of meta-analysis. Benefits reported for hydrolysed formulas were inconsistent. Based on available evidence, we are unable to recommend any intervention. Future studies of single interventions, using clinically significant outcome measures, and appropriate design and power are needed

  • Pain-relieving agents for Infantile Colic
    'Wiley', 2016
    Co-Authors: E. Biagioli, V. Tarasco, C. Lingua, L. Moja, F Savino
    Abstract:

    Background: Infantile Colic is a common disorder in the first months of life, affecting somewhere between 4% and 28% of infants worldwide, depending on geography and definitions used. Although it is self limiting and resolves by four months of age, Colic is perceived by parents as a problem that requires action. Pain-relieving agents, such as drugs, sugars and herbal remedies, have been suggested as interventions to reduce crying episodes and severity of symptoms. Objectives: To assess the effectiveness and safety of pain-relieving agents for reducing Colic in infants younger than four months of age. Search methods: We searched the following databases in March 2015 and again in May 2016: CENTRAL, Ovid MEDLINE, Embase and PsycINFO, along with 11 other databases. We also searched two trial registers, four thesis repositories and the reference lists of relevant studies to identify unpublished and ongoing studies. Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of pain-relieving agents given to infants with Colic. Data collection and analysis: We used the standard methodological procedures of The Cochrane Collaboration. Main results: We included 18 RCTs involving 1014 infants. All studies were small and at high risk of bias, often presenting major shortcomings across multiple design factors (e.g. selection, performance, attrition, lack of washout period). Three studies compared simethicone with placebo, and one with Mentha piperita; four studies compared herbal agents with placebo; two compared sucrose or glucose with placebo; five compared dicyclomine with placebo; and two compared cimetropium - one against placebo and the other at two different dosages. One multiple-arm study compared sucrose and herbal tea versus no treatment. Simethicone. Comparison with placebo revealed no difference in daily hours of crying reported for simethicone at the end of treatment in one small, low-quality study involving 27 infants. A meta-analysis of data from two cross-over studies comparing simethicone with placebo showed no difference in the number of of infants who responded positively to treatment (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.73 to 1.23; 110 infants, low-quality evidence). One small study (30 participants) compared simethicone with Mentha piperita and found no difference in crying duration, number of crying episodes or number of responders. Herbal agents. We found low-quality evidence suggesting that herbal agents reduce the duration of crying compared with placebo (mean difference (MD) 1.33, 95% CI 0.71 to 1.96; three studies, 279 infants), with different magnitude of benefit noted across studies (I2 = 96%). We found moderate-quality evidence indicating that herbal agents increase response over placebo (RR 2.05, 95% CI 1.56 to 2.70; three studies, 277 infants). Sucrose. One very low-quality study involving 35 infants reported that sucrose reduced hours spent crying compared with placebo (MD 1.72, 95% CI 1.38 to 2.06). Dicyclomine. We could consider only one of the five studies of dicyclomine (48 infants) for the primary comparison. In this study, more of the infants given dicyclomine responded than than those given placebo (RR 2.50, 95% CI 1.17 to 5.34). Cimetropium bromide. Data from one very low-quality study comparing cimetropium bromide with placebo showed reduced crying duration among infants treated with cimetropium bromide (MD -30.20 minutes per crisis, 95% CI -39.51 to -20.89; 86 infants). The same study reported that cimetropium increased the number of responders (RR 2.29, 95% CI 1.44 to 3.64). No serious adverse events were reported for all of the agents considered, with the exception of dicyclomine, for which two of five studies reported relevant adverse effects (longer sleep 4%, wide-eyed state 4%, drowsiness 13%). Authors' conclusions: At the present time, evidence of the effectiveness of pain-relieving agents for the treatment of Infantile Colic is sparse and prone to bias. The few available studies included small sample sizes, and most had serious limitations. Benefits, when reported, were inconsistent. We found no evidence to support the use of simethicone as a pain-relieving agent for Infantile Colic. Available evidence shows that herbal agents, sugar, dicyclomine and cimetropium bromide cannot be recommended for infants with Colic. Investigators must conduct RCTs using standardised measures that allow comparisons among pain-relieving agents and pooling of results across studies. Parents, who most often provide the intervention and assess the outcome, should always be blinded

  • lactobacillus reuteri dsm 17938 in Infantile Colic a randomized double blind placebo controlled trial
    Pediatrics, 2010
    Co-Authors: F Savino, E Palumeri, R Oggero, Lisa Cordisco, Valentina Tarasco, Roberto Calabrese, Stefan Roos, Diego Matteuzzi
    Abstract:

    OBJECTIVE: To test the efficacy of Lactobacillus reuteri on Infantile Colic and to evaluate its relationship to the gut microbiota. STUDY DESIGN: Fifty exclusively breastfed Colicky infants, diagnosed according to modified Wessel9s criteria, were randomly assigned to receive either L reuteri DSM 17 938 (108 colony-forming units) or placebo daily for 21 days. Parental questionnaires monitored daily crying time and adverse effects. Stool samples were collected for microbiologic analysis. RESULTS: Forty-six infants (L reuteri group: 25; placebo group: 21) completed the trial. Daily crying times in minutes/day (median [interquartile range]) were 370 (120) vs 300 (150) (P = .127) on day 0 and 35.0 (85) vs 90.0 (148) (P = .022) on day 21, in the L reuteri and placebo groups, respectively. Responders (50% reduction in crying time from baseline) were significantly higher in the L reuteri group versus placebo group on days 7 (20 vs 8; P = .006), 14 (24 vs 13; P = .007), and 21 (24 vs 15; P = .036). During the study, there was a significant increase in fecal lactobacilli (P = .002) and a reduction in fecal Escherichia coli and ammonia in the L reuteri group only (P = .001). There were no differences in weight gain, stooling frequency, or incidence of constipation or regurgitation between groups, and no adverse events related to the supplementation were observed. CONCLUSION: L. reuteri DSM 17 938 at a dose of 108 colony-forming units per day in early breastfed infants improved symptoms of Infantile Colic and was well tolerated and safe. Gut microbiota changes induced by the probiotic could be involved in the observed clinical improvement.

  • lactobacillus reuteri american type culture collection strain 55730 versus simethicone in the treatment of Infantile Colic a prospective randomized study
    Pediatrics, 2007
    Co-Authors: F Savino, Emanuela Pelle, E Palumeri, R Oggero, R Miniero
    Abstract:

    OBJECTIVE. The goal was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized study would improve symptoms of Infantile Colic. METHODS. Ninety breastfed Colicky infants were assigned randomly to receive either the probiotic L reuteri (10 8 live bacteria per day) or simethicone (60 mg/day) each day for 28 days. The mothers avoided cow’s milk in their diet. Parents monitored daily crying times and adverse effects by using a questionnaire. RESULTS. Eighty-three infants completed the trial: 41 in the probiotic group and 42 in the simethicone group. The infants were similar regarding gestational age, birth weight, gender, and crying time at baseline. Daily median crying times in the probiotic and simethicone groups were 159 minutes/day and 177 minutes/day, respectively, on the seventh day and 51 minutes/day and 145 minutes/day on the 28th day. On day 28, 39 patients (95%) were responders in the probiotic group and 3 patients (7%) were responders in the simethicone group. No adverse effects were reported. CONCLUSIONS. In our cohort, L reuteri improved Colicky symptoms in breastfed infants within 1 week of treatment, compared with simethicone, which suggests that probiotics may have a role in the treatment of Infantile Colic.

Gideon Koren - One of the best experts on this subject based on the ideXlab platform.

  • probiotics for Infantile Colic a randomized double blind placebo controlled trial investigating lactobacillus reuteri dsm 17938
    The Journal of Pediatrics, 2015
    Co-Authors: Kim Chau, Eddy Lau, Saul Greenberg, Sheila Jacobson, Parvaneh Yazdanibrojeni, Natasha Verma, Gideon Koren
    Abstract:

    Objective To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of Infantile Colic in breastfed Canadian infants, compared with placebo. Study design A randomized, double-blind, placebo-controlled trial was conducted involving 52 infants with Colic, according to modified Wessel criteria, who were assigned at random to receive L reuteri DSM 17938 (10 8  colony-forming units) (n = 24) or placebo (n = 28) for 21 days. Daily crying and fussing times were recorded in a structured diary, and maternal questionnaires were completed to monitor changes in infant Colic symptoms and adverse events. Results Total average crying and fussing times throughout the study (from baseline to day 21) were significantly shorter among infants with Colic in the probiotic group compared with infants in the placebo group (1719 ± 750 minutes [29 ± 13 hours] vs 2195 ± 764 minutes [37 ± 13 hours]; P  = .028) (relative risk, 0.78; 95% CI, 0.58-0.98). Infants given L reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo (median, 60 minutes/day [IQR, 64 minutes/day] vs 102 minutes/day [IQR, 87 minutes/day]; P  = .045). On day 21, a significantly higher proportion of infants in the L reuteri DSM 17938 group responded to treatment with a ≥50% crying time reduction compared with infants given placebo (17 vs 6, P  = .035; relative risk, 3.3; 95% CI, 1.55-7.03). Conclusion Administration of L reuteri DSM 17938 significantly improved Colic symptoms by reducing crying and fussing times in breastfed Canadian infants with Colic.

Andrea Horvath - One of the best experts on this subject based on the ideXlab platform.

  • lactobacillus reuteri dsm 17938 for the management of Infantile Colic in breastfed infants a randomized double blind placebo controlled trial
    The Journal of Pediatrics, 2013
    Co-Authors: Hania Szajewska, Ewa Gyrczuk, Andrea Horvath
    Abstract:

    Objective To determine whether administration of Lactobacillus reuteri ( L reuteri ) DSM 17938 is beneficial in breastfed infants with Infantile Colic. Study design Eighty infants aged 50%) breastfed were randomly assigned to receive L reuteri DSM 17938 (10 8 colony-forming units) (n = 40) or an identically appearing and tasting placebo (n = 40), both orally, in 5 drops, 1 time daily, for 21 days. The primary outcome measures were the treatment success, defined as the percentage of children achieving a reduction in the daily average crying time ≥50%, and the duration of crying (minutes per day) at 7, 14, 21, and 28 days after randomization. Results The rate of responders to treatment was significantly higher in the probiotic group compared with the placebo group at day 7 ( P  = .026), at day 14 (relative risk (RR) 4.3, 95% CI 2.3-8.7), at day 21 (RR 2.7, 95% CI 1.85-4.1), and at day 28 (RR 2.5, 95% CI 1.8-3.75). In addition, throughout the study period, the median crying time was significantly reduced in the probiotic group compared with the control group. Conclusion Exclusively or predominantly breastfed infants with Infantile Colic benefit from the administration of L reuteri DSM 17938 compared with placebo.

Diego Matteuzzi - One of the best experts on this subject based on the ideXlab platform.

  • lactobacillus reuteri dsm 17938 in Infantile Colic a randomized double blind placebo controlled trial
    Pediatrics, 2010
    Co-Authors: F Savino, E Palumeri, R Oggero, Lisa Cordisco, Valentina Tarasco, Roberto Calabrese, Stefan Roos, Diego Matteuzzi
    Abstract:

    OBJECTIVE: To test the efficacy of Lactobacillus reuteri on Infantile Colic and to evaluate its relationship to the gut microbiota. STUDY DESIGN: Fifty exclusively breastfed Colicky infants, diagnosed according to modified Wessel9s criteria, were randomly assigned to receive either L reuteri DSM 17 938 (108 colony-forming units) or placebo daily for 21 days. Parental questionnaires monitored daily crying time and adverse effects. Stool samples were collected for microbiologic analysis. RESULTS: Forty-six infants (L reuteri group: 25; placebo group: 21) completed the trial. Daily crying times in minutes/day (median [interquartile range]) were 370 (120) vs 300 (150) (P = .127) on day 0 and 35.0 (85) vs 90.0 (148) (P = .022) on day 21, in the L reuteri and placebo groups, respectively. Responders (50% reduction in crying time from baseline) were significantly higher in the L reuteri group versus placebo group on days 7 (20 vs 8; P = .006), 14 (24 vs 13; P = .007), and 21 (24 vs 15; P = .036). During the study, there was a significant increase in fecal lactobacilli (P = .002) and a reduction in fecal Escherichia coli and ammonia in the L reuteri group only (P = .001). There were no differences in weight gain, stooling frequency, or incidence of constipation or regurgitation between groups, and no adverse events related to the supplementation were observed. CONCLUSION: L. reuteri DSM 17 938 at a dose of 108 colony-forming units per day in early breastfed infants improved symptoms of Infantile Colic and was well tolerated and safe. Gut microbiota changes induced by the probiotic could be involved in the observed clinical improvement.

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

  • lactobacillus reuteri dsm 17938 in Infantile Colic a randomized double blind placebo controlled trial
    Pediatrics, 2010
    Co-Authors: F Savino, E Palumeri, R Oggero, Lisa Cordisco, Valentina Tarasco, Roberto Calabrese, Stefan Roos, Diego Matteuzzi
    Abstract:

    OBJECTIVE: To test the efficacy of Lactobacillus reuteri on Infantile Colic and to evaluate its relationship to the gut microbiota. STUDY DESIGN: Fifty exclusively breastfed Colicky infants, diagnosed according to modified Wessel9s criteria, were randomly assigned to receive either L reuteri DSM 17 938 (108 colony-forming units) or placebo daily for 21 days. Parental questionnaires monitored daily crying time and adverse effects. Stool samples were collected for microbiologic analysis. RESULTS: Forty-six infants (L reuteri group: 25; placebo group: 21) completed the trial. Daily crying times in minutes/day (median [interquartile range]) were 370 (120) vs 300 (150) (P = .127) on day 0 and 35.0 (85) vs 90.0 (148) (P = .022) on day 21, in the L reuteri and placebo groups, respectively. Responders (50% reduction in crying time from baseline) were significantly higher in the L reuteri group versus placebo group on days 7 (20 vs 8; P = .006), 14 (24 vs 13; P = .007), and 21 (24 vs 15; P = .036). During the study, there was a significant increase in fecal lactobacilli (P = .002) and a reduction in fecal Escherichia coli and ammonia in the L reuteri group only (P = .001). There were no differences in weight gain, stooling frequency, or incidence of constipation or regurgitation between groups, and no adverse events related to the supplementation were observed. CONCLUSION: L. reuteri DSM 17 938 at a dose of 108 colony-forming units per day in early breastfed infants improved symptoms of Infantile Colic and was well tolerated and safe. Gut microbiota changes induced by the probiotic could be involved in the observed clinical improvement.

  • lactobacillus reuteri american type culture collection strain 55730 versus simethicone in the treatment of Infantile Colic a prospective randomized study
    Pediatrics, 2007
    Co-Authors: F Savino, Emanuela Pelle, E Palumeri, R Oggero, R Miniero
    Abstract:

    OBJECTIVE. The goal was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized study would improve symptoms of Infantile Colic. METHODS. Ninety breastfed Colicky infants were assigned randomly to receive either the probiotic L reuteri (10 8 live bacteria per day) or simethicone (60 mg/day) each day for 28 days. The mothers avoided cow’s milk in their diet. Parents monitored daily crying times and adverse effects by using a questionnaire. RESULTS. Eighty-three infants completed the trial: 41 in the probiotic group and 42 in the simethicone group. The infants were similar regarding gestational age, birth weight, gender, and crying time at baseline. Daily median crying times in the probiotic and simethicone groups were 159 minutes/day and 177 minutes/day, respectively, on the seventh day and 51 minutes/day and 145 minutes/day on the 28th day. On day 28, 39 patients (95%) were responders in the probiotic group and 3 patients (7%) were responders in the simethicone group. No adverse effects were reported. CONCLUSIONS. In our cohort, L reuteri improved Colicky symptoms in breastfed infants within 1 week of treatment, compared with simethicone, which suggests that probiotics may have a role in the treatment of Infantile Colic.

  • reduction of crying episodes owing to Infantile Colic a randomized controlled study on the efficacy of a new infant formula
    European Journal of Clinical Nutrition, 2006
    Co-Authors: Francesco Savino, E Palumeri, Emanuele Castagno, F Cresi, Paola Dalmasso, Franco Cavallo, R Oggero
    Abstract:

    Reduction of crying episodes owing to Infantile Colic: a randomized controlled study on the efficacy of a new infant formula