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

Conditions:		Colic
Purpose:		It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.
Study Summary:
Criteria:		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
NCT ID:		NCT01067027
Primary Contact:		Principal Investigator Bryan M Harvey, M.D. Children's Investigational Research Program Misty R Ross, MA Phone: 479-254-6772 ext. 21 Email: mross@chirpresearch.com
Backup Contact:		N/A
Location Contact:		Bentonville, Arkansas 72712 United States Misty R Ross, MA Phone: 479-254-6772 Email: mross@chirpresearch.com Site Status: Recruiting

Data Source:		ClinicalTrials.gov
Date Processed:		June 19, 2013
Modifications to this listing:		Only selected fields are shown, please use the link below to view all information about this clinical trial.
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