Bentonville, Arkansas 72712

  • Colic

Purpose:

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


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: July 28, 2021

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