Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
Lead SponsorChildren's Investigational Research Program, LLC
Intervention/Treatmentlactobacillus reuteri ...
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.
5 drops of study product 30 minutes before feeding.
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