Evidence map›Paper›PMID 24690625›Full record

Trial reportBMJ (Clinical research ed.)2014

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

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

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 85 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 10 pooled it
64.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02574065 naunknown statusnot on this mapstarted 2016, after this paper: background citation

Effects on Crying Time in Colicky Infants With the Supplementation of Lactobacillus Reuteri DSM 17938: A Randomized, Double Blind, Placebo-controlled Study

TypeinterventionalSponsorShanghai Children's HospitalRan2016Enrolled116ConditionsCrying Time in Colicky InfantsArmsL. reuteri DSM 17938, The placebo consists of an identical formulation without L. reuteri DSM 17938
NCT03219931 phase4completednot on this map

Effects of an Association of the Two Bifidobacteria Probiotics Bifidobacterium Breve B632 and Bifidobacterium Breve BR03 in Intestinal Bacterial Colonization and in the Prevention and/or Reduction of the Incidence of Colics in Infants

TypeinterventionalSponsorAzienda Ospedaliero Universitaria Maggiore della CaritaRan2013 to 2017Enrolled320ConditionsColic, Infantile, Probiotic, Gut Microbiome, Bifidobacterium BreveArmsBifidobacterium breve BR03 and Bifidobacterium breve B632, Placebos
3 · Its place in the literature

Who cites it

85 citing papers in PubMed, 10 syntheses or guidelines pooled it, 244 citations in OpenAlex.

  1. Pooled it
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  3. Probiotics to prevent infantile colic.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Dietary modifications for infantile colic.The Cochrane database of systematic reviews · 2018
    Pooled it
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  17. The Efficacy of the Administration ofAdvanced biomedical research · 2026
    Article
  18. Article
  19. Observational
  20. International journal of molecular sciences · 2025
    Article

25 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

Valerie SungRoyal Children's Hospital, Parkville, Victoria, Australia.
Harriet Hiscock
Mimi L K Tang
Fiona K Mensah
Monica L Nation
Catherine Satzke
Ralf G Heine
Amanda Stock
Ronald G Barr
Melissa Wake
Murdoch Children's Research Institute · AURoyal Children's Hospital · AUUniversity of Melbourne · AUChild and Family Research Institute · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 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.

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.

Indexed as

ColicDouble-Blind MethodFemaleHumansInfantInfant BehaviorLimosilactobacillus reuteriMaleProbioticsTreatment Outcome

Identifiers

PMID24690625
PMCPMC3972414
OpenAlexW2120931944

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.