Clinical Trial

Effect of Probiotics on Infant's Fecal Microbiota Composition

Study acronym: BABYCARE
Recruiting
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Record status
This record was last updated February 11, 2025 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-08-30; most recent amendment 2025-02-10.
Trial Details
NCT Number NCT05524649
Lead Sponsor AB Biotics, SA
Collaborators: Ministry of Science and Innovation, Spain
Conditions Microbial Colonization
Enrollment 120 participants
Start Date 2022-06-01
Primary Completion 2025-08-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-11