NCT01541046

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

Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic: A Randomized Double-blind Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 21 Days – 180 Days
• Healthy volunteers: Not accepted

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.

Detailed description

Infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians. The reported incidence of infantile colic ranges from 3% to 28% in prospective studies and up to 40% in retrospective surveys. The pathogenesis of infantile colic remains elusive despite decades of research. It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. Consequently, various treatment approaches have been tried to alleviate this condition. Recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. Therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.

Conditions

• Colic

Interventions

Type	Name	Description
BIOLOGICAL	Biogaia L. reuteri DSM 17938	Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™
BIOLOGICAL	Probiotic Placebo	Description of Placebo: contains same excipients as Active Agent, without the active ingredient

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-02-29
• Last updated: 2014-11-20

Locations

1 site across 1 country: Canada