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

Status unconfirmed · Phase 4

Conditions studied: Colic

In brief

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

Key facts

Study ID

NCT01067027

Run by

Children's Investigational Research Program, LLC

People needed

50

Starts

2009-06-01

Expected to finish

2012-06-01

Last updated by the study team

2011-06-29

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Investigational Research Program — Bentonville, Arkansas, United States (enrolling)

Full record on ClinicalTrials.gov

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