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

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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  • Authors+Show Affiliations

    ,

    Royal Children's Hospital, Parkville, Victoria, Australia.

    , , , , , , , ,

    Source

    BMJ (Clinical research ed.) 348: 2014 Apr 01 pg g2107

    MeSH

    Colic
    Double-Blind Method
    Female
    Humans
    Infant
    Infant Behavior
    Lactobacillus reuteri
    Male
    Probiotics
    Treatment Outcome

    Pub Type(s)

    Clinical Trial, Phase III
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    24690625

    Citation

    Sung, Valerie, et al. "Treating Infant Colic With the Probiotic Lactobacillus Reuteri: Double Blind, Placebo Controlled Randomised Trial." BMJ (Clinical Research Ed.), vol. 348, 2014, pp. g2107.
    Sung V, Hiscock H, Tang ML, et al. Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. BMJ. 2014;348:g2107.
    Sung, V., Hiscock, H., Tang, M. L., Mensah, F. K., Nation, M. L., Satzke, C., ... Wake, M. (2014). Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. BMJ (Clinical Research Ed.), 348, pp. g2107. doi:10.1136/bmj.g2107.
    Sung V, et al. Treating Infant Colic With the Probiotic Lactobacillus Reuteri: Double Blind, Placebo Controlled Randomised Trial. BMJ. 2014 Apr 1;348:g2107. PubMed PMID: 24690625.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. AU - Sung,Valerie, AU - Hiscock,Harriet, AU - Tang,Mimi L K, AU - Mensah,Fiona K, AU - Nation,Monica L, AU - Satzke,Catherine, AU - Heine,Ralf G, AU - Stock,Amanda, AU - Barr,Ronald G, AU - Wake,Melissa, Y1 - 2014/04/01/ PY - 2014/4/3/entrez PY - 2014/4/3/pubmed PY - 2014/7/6/medline SP - g2107 EP - g2107 JF - BMJ (Clinical research ed.) JO - BMJ VL - 348 N2 - 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. SN - 1756-1833 UR - https://www.unboundmedicine.com/medline/citation/24690625/full_citation L2 - http://www.bmj.com/cgi/pmidlookup?view=long&pmid=24690625 DB - PRIME DP - Unbound Medicine ER -