NCT01887444

Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic

The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioGaia AB · Industry
• Sex: All
• Age: 29 Days – 3 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time \>50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.

Detailed description

NOTE: The study never started.

Conditions

• Infantile Colic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus reuteri DSM17938 probiotic	Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to 2.108 CFU Lactobacillus reuteri living DSM17938. The probiotic is contained in a lipid emulsion.
OTHER	Placebo	Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-05-01
• Completion: 2014-09-01
• First posted: 2013-06-26
• Last updated: 2021-02-04

Locations

1 site across 1 country: France