NCT05524649

Effect of Probiotics on Infant's Fecal Microbiota Composition

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: AB Biotics, SA · Industry
• Sex: All
• Age: 1 Day – 90 Days
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Microbial Colonization

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Food Supplement 1	Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day
DIETARY_SUPPLEMENT	Food Supplement 2	Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day
DIETARY_SUPPLEMENT	Placebo	5 drops/day for 3 months of sunflower oil

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2022-09-01
• Last updated: 2025-02-11

Locations

2 sites across 2 countries: Mexico, Spain