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Clinical Trial
. 2014 Apr 1:348:g2107.
doi: 10.1136/bmj.g2107.

Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial

Valerie Sung  1 , Harriet Hiscock, Mimi L K Tang, Fiona K Mensah, Monica L Nation, Catherine Satzke, Ralf G Heine, Amanda Stock, Ronald G Barr, Melissa Wake
Affiliations
Clinical Trial

Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial

Valerie Sung et al. BMJ. .

Abstract

Objective: To 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.

Design: Double blind, placebo controlled randomised trial.

Setting: Community based sample (primary and secondary level care centres) in Melbourne, Australia.

Participants: 167 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.

Interventions: Oral daily L reuteri (1 × 10(8) colony forming units) versus placebo for one month.

Main outcomes measures: The 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.

Results: Of 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.

Conclusions: L 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 registration: Current Controlled Trials ISRCTN95287767.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare that: VS, HH, FM, and MW have support from the Australian National Health and Medical Research Council for the submitted work; RB is supported by a Canada research chair in community child health research and by the Child and Family Research Institute of BC Children’s Hospital; MT is a member of the Nestlé Nutrition Institute Medical Advisory Board Oceania and the Nutricia Medical Advisory Board Australasia, received honorariums for speaking at symposiums sponsored by Nestlé Nutrition Institute and Nutricia (Danone), and received probiotic and placebo research products from Nestlé Research Centre Switzerland and Dicofarm Italy for studies unrelated to this trial; RH is a member of the Nestlé Nutrition Institute Medical Advisory Board Oceania and the Nutricia Medical Advisory Board Australasia and received honorariums for speaking at symposiums sponsored by Nestlé Nutrition Institute and Nutricia (Danone); the authors’ spouses, partners, or children have no financial relationships that may be relevant to the submitted work; and the authors have no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Fig 1 Participant flow through study
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Fig 2 Daily duration of cry or fuss over study period and at 6 month follow-up. Day 28=1 month; day 183=6 months
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Fig 3 Meta-analysis of previous randomised controlled trials of probiotics for management of infant colic (outcomes at 21 days post-intervention)
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Fig 4 Meta-analysis of previous randomised controlled trials of probiotics for management of infant colic with addition of results from this study
See this image and copyright information in PMC

Comment in

References

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