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Effect of Probiotics on Infant's Fecal Microbiota Composition
Sponsor: AB Biotics, SA
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
Conditions
Interventions
Food Supplement 1
Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day
Food Supplement 2
Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day
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