Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938

Kim Chau; Eddy Lau; Saul Greenberg; Sheila Jacobson; Parvaneh Yazdani-Brojeni; Natasha Verma; Gideon Koren

doi:10.1016/j.jpeds.2014.09.020

Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938

J Pediatr. 2015 Jan;166(1):74-8. doi: 10.1016/j.jpeds.2014.09.020. Epub 2014 Oct 23.

Authors

Kim Chau¹, Eddy Lau², Saul Greenberg³, Sheila Jacobson⁴, Parvaneh Yazdani-Brojeni⁵, Natasha Verma⁵, Gideon Koren⁶

Affiliations

¹ Department of Pharmacology and Toxicology, University of Toronto, Ontario, Canada; Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Ontario, Canada.
² Department of Pediatrics, University of Toronto, Ontario, Canada; Department of Emergency Medicine, The Hospital for Sick Children, Ontario, Canada; Department of Pediatrics, St Joseph's Health Care, Ontario, Canada.
³ Department of Pediatric Medicine, The Hospital for Sick Children, Ontario, Canada.
⁴ Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Ontario, Canada; Department of Pediatric Medicine, The Hospital for Sick Children, Ontario, Canada.
⁵ Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Ontario, Canada.
⁶ Department of Pharmacology and Toxicology, University of Toronto, Ontario, Canada; Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Ontario, Canada; Department of Pediatrics, University of Toronto, Ontario, Canada; Department of Pediatric Medicine, The Hospital for Sick Children, Ontario, Canada; Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada. Electronic address: gkoren@sickkids.ca.

PMID: 25444531
DOI: 10.1016/j.jpeds.2014.09.020

Abstract

Objective: To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants, compared with placebo.

Study design: A randomized, double-blind, placebo-controlled trial was conducted involving 52 infants with colic, according to modified Wessel criteria, who were assigned at random to receive L reuteri DSM 17938 (10(8) colony-forming units) (n = 24) or placebo (n = 28) for 21 days. Daily crying and fussing times were recorded in a structured diary, and maternal questionnaires were completed to monitor changes in infant colic symptoms and adverse events.

Results: Total average crying and fussing times throughout the study (from baseline to day 21) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group (1719 ± 750 minutes [29 ± 13 hours] vs 2195 ± 764 minutes [37 ± 13 hours]; P = .028) (relative risk, 0.78; 95% CI, 0.58-0.98). Infants given L reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo (median, 60 minutes/day [IQR, 64 minutes/day] vs 102 minutes/day [IQR, 87 minutes/day]; P = .045). On day 21, a significantly higher proportion of infants in the L reuteri DSM 17938 group responded to treatment with a ≥50% crying time reduction compared with infants given placebo (17 vs 6, P = .035; relative risk, 3.3; 95% CI, 1.55-7.03).

Conclusion: Administration of L reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic.

Trial registration: ClinicalTrials.gov NCT01541046.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Breast Feeding
Canada
Colic / therapy*
Crying
Double-Blind Method
Female
Humans
Infant
Infant, Newborn
Limosilactobacillus reuteri*
Male
Probiotics / therapeutic use*

Associated data

ClinicalTrials.gov/NCT01541046