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Pediatrics. 2018 Jan;141(1). pii: e20171811. doi: 10.1542/peds.2017-1811.

Lactobacillus reuteri to Treat Infant Colic: A Meta-analysis.

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Murdoch Children's Research Institute, The Royal Children's Hospital, and the University of Melbourne, Melbourne, Victoria, Australia;
Department of Mathematics, Duquesne University, Pittsburgh, Pennsylvania.
University of Pittsburgh Medical Center St. Margaret's Hospital, Pittsburgh, Pennsylvania.
Department of Pediatrics, Epidemiology and Biostatistics, School of Medicine, University of California, San Francisco, San Francisco, California.
University of Toronto and The Hospital for Sick Children, Toronto, Ontario, Canada.
Ospendale Infantile Regina Margherita, Citta della Salute e della Scienza di Torino, Torino, Italy.
Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
Department of Neonatology, Nepean Hospital and Sydney Medical School Nepean, University of Sydney, Sydney, New South Wales, Australia.
Department of Pediatric Gastroenterology, Paris Descartes University and Necker-Enfants Malades Hospital, Paris, France.
Department of Pediatrics, University of Bari, Bari, Italy.
Bacteriology Unit, National Institute for Health and Welfare, Helsinki, Finland.
Department of Pediatrics and Adolescent Medicine, Turku University Hospital, Turku, Finland; and.
Department of Pediatrics, University of California Davis Health System, Sacramento, California.



Lactobacillus reuteri DSM17938 has shown promise in managing colic, but conflicting study results have prevented a consensus on whether it is truly effective.


Through an individual participant data meta-analysis, we sought to definitively determine if L reuteri DSM17938 effectively reduces crying and/or fussing time in infants with colic and whether effects vary by feeding type.


We searched online databases (PubMed, Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature, the Database of Abstracts of Reviews of Effects, and Cochrane), e-abstracts, and clinical trial registries.


These were double-blind randomized controlled trials (published by June 2017) of L reuteri DSM17398 versus a placebo, delivered orally to infants with colic, with outcomes of infant crying and/or fussing duration and treatment success at 21 days.


We collected individual participant raw data from included studies modeled simultaneously in multilevel generalized linear mixed-effects regression models.


Four double-blind trials involving 345 infants with colic (174 probiotic and 171 placebo) were included. The probiotic group averaged less crying and/or fussing time than the placebo group at all time points (day 21 adjusted mean difference in change from baseline [minutes] -25.4 [95% confidence interval (CI): -47.3 to -3.5]). The probiotic group was almost twice as likely as the placebo group to experience treatment success at all time points (day 21 adjusted incidence ratio 1.7 [95% CI: 1.4 to 2.2]). Intervention effects were dramatic in breastfed infants (number needed to treat for day 21 success 2.6 [95% CI: 2.0 to 3.6]) but were insignificant in formula-fed infants.


There were insufficient data to make conclusions for formula-fed infants with colic.


L reuteri DSM17938 is effective and can be recommended for breastfed infants with colic. Its role in formula-fed infants with colic needs further research.

[Indexed for MEDLINE]
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Conflict of interest statement

POTENTIAL CONFLICT OF INTEREST: Dr Sung reports personal fees from Mead Johnson Nutrition outside the submitted work; Dr Tancredi reports personal fees from Pfizer Consumer Healthcare outside the submitted work; Dr Cabana reports personal fees from BioGaia outside the submitted work; Dr Szajewska reports personal fees from BioGaia outside the submitted work; and Dr Dupont reports on the following outside the submitted work: Nutricia Research’s Scientific Advisory Board, Nestle Health Science Scientific Advisory Board, Sodilac Consulting, and Novalac clinical trials. Dr Savino reports the following outside the submitted work: received fees for scientific consultancy from Nestlé Italia (Assago, Milan), HiPP GmbH & Company Vertrieb KG (Germany), and Danone Trading BV (Amsterdam); he receives royalties from Springer for the book Nutrizione Parenterale in Pediatria and declares that the book does not cover any interventions investigated in the article and is outside the submitted work; he has received travel grants, accommodations, and meeting expenses from Cana Pharmaceutical Laboratories (Iraklio, Attica), Radiotelevisione Italiana (Rome), Nestlé Italy, and Nestlé France; he has received personal fees from Mead Johnson Nutrition Italy, Cana Laboratories (Thessaloniki, Greece), Nutricia (part of Groupe Danone; Dubai, United Arab Emirates, and Kuwait); HiPP GmbH & Company Vertrieb KG (Germany), and Menarini Farmaceutica Internazionale (Firenze); and he declares that none of these companies had any input or involvement in any aspect of the manuscript conducted by him or have a real or vested interest in the findings of the article. Dr Indrio reports, outside of the submitted work, being a consultant for BioGaia for an educational program for its Web site and being a speaker for the bureaus for the Nestle Nutrition Institute, Abbot Danone, and BioGaia at scientific events and lectures; and the other authors have indicated they have no potential conflicts of interest to disclose.

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