Original ArticleLactobacillus reuteri DSM 17938 for the Management of Infantile Colic in Breastfed Infants: A Randomized, Double-Blind, Placebo-Controlled Trial
Section snippets
Methods
The standards from the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) were followed for this RCT. The trial was registered at ClinicalTrials.gov (NCT01046617). All infants were eligible for recruitment after written informed consent was obtained from their parents. The study was approved by the Ethics Committee of the Medical University of Warsaw.
The study was carried out between January 2010 and December 2011 in a family primary care practice in Warsaw, Poland. To be
Results
The Figure is a flow diagram showing the subjects' progression through the study. The intention-to-treat population included 80 infants—40 were assigned to the probiotic group and 40 were assigned to the placebo group. Baseline demographic and clinical characteristics did not differ between the 2 groups, except for a family history of allergy that was higher in the probiotic group compared with the placebo group (21/40 vs 7/40 infants) (Table I).
The treatment success rate was significantly
Discussion
Administration of L reuteri DSM 17938 at a dose 108 colony-forming units to exclusively or predominantly breastfed infants is superior to placebo for the management of infantile colic. The use of L reuteri was associated with the treatment success and reduced crying times at 1, 2, 3, and 4 weeks after randomization. No adverse events were recorded during the treatment.
In principle, our findings are consistent with the findings of a previous smaller trial by Savino et al,7 which used the same
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Efficacy of a partially hydrolysed formula, with reduced lactose content and with Lactobacillus reuteri DSM 17938 in infant colic: A double blind, randomised clinical trial
2021, Clinical NutritionCitation Excerpt :Several studies indicate that inadequate lactobacilli in the first few months of life may affect intestinal fatty acid profile favouring IC development, while coliform bacteria have been found more abundantly in colicky infants [15]. On the basis of this rationale 3 different trials and 2 metanalyses showed that administration of Lactobacillus reuteri DSM 17938 (L. reuteri) improved colic symptoms by reducing crying and fussing times in breastfed colicky infants [16–20]. In contrast, one double blind, placebo controlled randomized trial on the same probiotic strain showed no efficacy in a community sample of Australian breast-fed infants and formula-fed infants with IC [12].
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Funded by the Medical University of Warsaw, which received a donation from the manufacturer of L reuteri DSM 17938, BioGaia AB, Lund, Sweden. The manufacturer had no role in the conception, design, or conduct of the study, or in the analysis or interpretation of the data. The authors declare no conflict of interest.
Registered at ClinicalTrials.gov: NCT01046617.