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Effect of Probiotics on Infant's Fecal Microbiota Composition — BABYCARE  

Microbial Colonization Clinical Trial

Official title:
Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants

Clinical Trial Summary

Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.

Clinical Trial Description

Double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains Bifidobacterium longum and Pediococcus pentosaceus on fecal microbiota composition in infants. Healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive Bifidobacterium longum, another group will receive Pediococcus pentosaceus and the other one will receive placebo for 3 months. Other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05524649
Study type Interventional
Source AB Biotics, SA
Contact Gerardo Rodríguez Martínez, MD
Phone 654633910
Email gerard@unizar.es
Status Recruiting
Phase N/A
Start date June 1, 2022
Completion date December 31, 2024
View Details
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