Probiotics for Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial Investigating Lactobacillus reuteri DSM 17938 - 24/10/14

Doi : 10.1016/j.jpeds.2014.09.020

Kim Chau, MSc ^1,², Eddy Lau, MD ^3,^4,⁵, Saul Greenberg, MD ⁶, Sheila Jacobson, MD ^2,⁶, Parvaneh Yazdani-Brojeni, MD ², Natasha Verma, MD ², Gideon Koren, MD ^1,^2,^3,^6,^7,^⁎
¹ Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada
² Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Toronto, Ontario, Canada
³ Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada
⁴ Department of Emergency Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada
⁵ Department of Pediatrics, St Joseph's Health Care, Toronto, Ontario, Canada
⁶ Department of Pediatric Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada
⁷ Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada

^∗Reprint requests: Gideon Koren, MD, Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, 555 University Ave, Toronto, ON M5G 1X8, Canada.

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Friday 24 October 2014

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 (10⁸ 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.

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Plan

Methods

Statistical Analyses

Results

Primary and Secondary Outcomes

Safety and Tolerance

Discussion

	Supported by the Research Leadership for Better Pharmacotherapy During Pregnancy and Lactation. The probiotic and placebo were supplied by Ferring Canada, Inc. The authors declare no conflicts of interest.
	Registered with ClinicalTrials.gov: NCT01541046.