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

Children's Investigational Research Program, LLC

Status and phase

Unknown

Phase 4

Conditions

Colic

Treatments

Dietary Supplement: Lactobacillus reuteri

Study type

Interventional

Funder types

Other

Identifiers

Colic001

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

14 to 60 days old

Volunteers

Accepts Healthy Volunteers

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