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Role of Lactobacillus rhamnosus (FloraActive™) 19070-2 and Lactobacillus reuteri (FloraActive™) 12246 in Infant Colic: A Randomized Dietary Study.

ABSTRACT: Infant colic is a common condition of unknown pathogenesis that brings frustration to families seeking for effective management. Accumulating evidence suggests that some single strains of lactobacilli may play a positive dietary role in attenuation of colic in exclusively breastfed infants. The objective of this study was to evaluate a mixture of two Lactobacillus strains in decreasing infant cry and fuss in this population. Infants aged 4?12 weeks received L. rhamnosus 19070-2 and L. reuteri 12246 in a daily dose of 250 × 10? CFU, 3.33 mg of fructooligosaccharide, and 200 IU of vitamin D? (84 infants, probiotic group) or just vitamin D? (84 infants, control group) for 28 days. Cry and fuss time were measured with validated Baby's Day Diary on days 0 and 28. At baseline, mean (SD) duration of cry and fuss time was comparable in the probiotic and control groups: 305 (81) vs. 315 (90) min., respectively (p = 0.450). On day 28, mean cry and fuss time became statistically different: 142 (89) vs. 199 (72), respectively (p < 0.05). Mean change in cry and fuss time from day 0 through day 28 was -163 (99) minutes in the probiotic and -116 (94) minutes in the control group (p = 0.019). Our findings confirm that lactobacilli decrease cry and fuss time and provide a dietary support in exclusively breastfed infants with colic.

SUBMITTER: Gerasimov S

PROVIDER: S-EPMC6315585 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.DesignDouble blind, placebo controlled randomised trial.SettingCommunity based sample (primary and secondary level care centres) in Melbourne, Australia.Participants167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel's criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.InterventionsOral daily L reuteri (1 × 10(8) colony forming units) versus placebo for one month.Main outcomes measuresThe primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.ResultsOf 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.ConclusionsL reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.Trial registrationCurrent Controlled Trials ISRCTN95287767.

Project description:AimTo investigate recruitment, retention, and estimates for effects of formula supplementation with Lactobacillus rhamnosus GG (LGG) on inflammatory biomarkers and fecal microbial community in infants with colic.MethodsA prospective, double-blind, placebo-controlled trial was conducted in otherwise healthy infants with colic. We screened 74 infants and randomized and analyzed results in 20 infants [9 receiving LGG (LGG+) and 11 not receiving LGG (LGG-)]. LGG was incorporated in the formula (Nutramigen(®)) (minimum of 3 × 10(7) CFU/d) in the LGG+ group. Fecal microbiota and inflammatory biomarkers, including fecal calprotectin (FC), plasma cytokines, circulating regulatory T cells (Tregs), and crying + fussing time were analyzed to determine optimal time points and effect sizes for a larger trial.ResultsRecruitment in this population was slow, with about 66% of eligible infants willing to enroll; subject retention was better (75%). These rates were influenced by parents' reluctance to volunteer their infant for a clinical trial and by their tendency to change formulas. The maximal difference of crying + fussing time was observed at day 14, comparing the 2 groups, with a mean difference of -91 (95%CI: -76, 259) min (P = NS). FC showed no significant difference, but the optimal time to determine a potential effect was at day 90 [with a mean difference of 121 (95%CI: -48, 291) μg/g stool], observing a lower level of FC in the LGG+ group. The fecal microbial communities were chaotic, as determined by Shannon's diversity index and not apparently influenced by the probiotic. No significant change was observed in plasma inflammatory cytokines or Tregs, comparing LGG+ to LGG- groups.ConclusionDesigning future colic trials involving a probiotic-supplemented formula for infants in the United States will require consideration for difficult enrollment. Infants with colic have major variations in feal microbiota and calprotectin, both of which improve with time, with optimal time points for measurement at days 14 and 90 after treatment.

Project description:BackgroundThe safety of an infant formula containing a new mixture of the prebiotics galacto-oligosaccharides (GOS) and fructo-oligosaccharide (FOS) and the probiotic Lactobacillus reuteri needs to be evaluated.MethodsHealthy term infants in Singapore were randomly assigned (using computer-generated allocation sequences) to receive exclusively an experimental infant formula containing L. reuteri, GOS (5.50 g/L), and FOS (0.36 g/L) or a control formula containing only L. reuteri from enrollment (7-14 days of age) to 4 months of age. The primary objective of this trial was to demonstrate that weight change between birth and 4 months of age in infants fed the experimental formula was not inferior to World Health Organization (WHO) Child Growth standards. The non-inferiority margin was -0.5 standard deviations (SD). The secondary objectives were to compare changes in anthropometric measurements (weight, length, body mass index, and head circumference), digestive tolerance, stool bacterial counts, urinary D- and L- lactate concentrations, and adverse events in the two formula groups.ResultsThe intention-to-treat (ITT) population included all randomized infants stratified by gender, (experimental group, N = 68 and control group, N = 72). The per-protocol (PP) population included 61 infants in the experimental and 62 infants in the control groups. The change in weight-for-age z-score between birth and 4 months was +0.93 (95% confidence interval [CI]: +0.63 to +1.23) SD in the experimental group and +0.92 (95% CI: +0.62 to +1.22) SD in the control group in the PP population, indicating non-inferior weight gain in both formulas groups compared with WHO standards. The ITT population had similar results. Liquid stools occurred more frequently in the experimental compared with the control group and median bifidobacteria, lactobacilli, and enterococci counts were higher in the experimental group (p < 0.05). Other secondary outcomes were not significantly different between groups.ConclusionsInfant formula containing L. reuteri + GOS/FOS supports normal growth and is safe.Trial registrationClinicalTrial.gov: NCT01010113.

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Role of Lactobacillus rhamnosus (FloraActive™) 19070-2 and Lactobacillus reuteri (FloraActive™) 12246 in Infant Colic: A Randomized Dietary Study.

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