Bentonville, Arkansas 72712

  • Colic


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


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



Primary Contact:

Principal Investigator
Bryan M Harvey, M.D.
Children's Investigational Research Program

Misty R Ross, MA
Phone: 479-254-6772 ext. 21

Backup Contact:


Location Contact:

Bentonville, Arkansas 72712
United States

Misty R Ross, MA
Phone: 479-254-6772

Site Status: Recruiting

Data Source:

Date Processed: July 28, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.