Clinical Trial: Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri

Brief Summary: It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.

Detailed Summary:
Sponsor: Children's Investigational Research Program, LLC

Current Primary Outcome: * Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents. [ Time Frame: 7, 14 and 21 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of responders versus non-responders with L. reuteri versus placebo at end of the study. [ Time Frame: 21 days ]

Original Secondary Outcome: Same as current

Information By: Children's Investigational Research Program, LLC

Dates:
Date Received: February 9, 2010
Date Started: June 2009
Date Completion: June 2012
Last Updated: June 28, 2011
Last Verified: June 2011