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
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