drugset / Trial / NCT01541046

Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic

NCT01541046

Phase 2 Completed 55 enrolled The Hospital for Sick Children
RandomizedParallel-groupTriple-blindTreatment

Summary

Infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. To fill the void in existing literature, we present a protocol to examine whether probiotics are effective in decreasing infantile colic symptoms when compared to placebo treatment. We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce symptoms of infantile colic in breastfed infants in comparison to placebo. An interim analysis will be conducted after 50 infants randomized to monitor both safety and efficacy.

Timeline

Start
2011-11
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactobacillus reuteri DSM 17938 Other / unclassified 1e+08 unknown Oral

Indications

No indication recorded.