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RECRUITING
NCT05524649
NA

Effect of Probiotics on Infant's Fecal Microbiota Composition

Sponsor: AB Biotics, SA

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Day - 90 Days

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-06-01

Completion Date

2025-12-31

Last Updated

2025-02-11

Healthy Volunteers

Yes

Interventions

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

Locations (2)

Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco

Alcaldía Coyoacán, Puebla, Mexico

Clínica Viamed Montecanal

Zaragoza, Aragon, Spain