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

Phase 4

• Conditions: Colic

• Registration Number: NCT01067027
• Lead Sponsor: Children's Investigational Research Program, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-10
• Study First Posted: 2010-02-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-28
• Last Update Posted: 2011-06-29
• Primary Completion: 2011-12
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Ifants aged between 14 and 60 days
• Breast fed, exclusively during length of trial
• Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.
• Debut of colic symptoms 6+/-1 days before randomization
• Gestational age between 37 and 42 weeks
• Apgar score higher than 7 at 5 minutes
• Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period
• Written informed consent from one or both parents
• Stated availability throughout the study period

Exclusion Criteria

• Major chronic disease
• Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria
• Administration of anitbiotics the week before randomization
• Administration of probiotics the week before randomization
• Participation in other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
* 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.	7, 14 and 21 days

Secondary Outcome Measures

Name	Time	Method
Number of responders versus non-responders with L. reuteri versus placebo at end of the study.	21 days

Trial Locations

Locations (1)

Children's Investigational Research Program; 🇺🇸 Bentonville, Arkansas, United States