Clinical Trial

Probiotics Supplementation for Neurodevelopment in Preterm Infants

Not Yet Recruiting
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Summary
The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure. The intervention lasts for 6 months. The study hypothesizes that early gut microbiota remodeling via exogenous probiotics can improve neurodevelopment. The primary outcome is assessed by the Gesell Developmental Schedules or the Ages \& Stages Questionnaires (ASQ-3). Secondary outcomes include longitudinal changes in gut microbiota composition,targeted metabolomics (such as short-chain fatty acids \[SCFAs\], and systemic inflammatory markers.
Trial Details
NCT Number NCT07617181
Lead Sponsor Fudan University
Conditions Premature Birth, Neurodevelopmental Disorders, Dysbiosis
Enrollment 116 participants
Start Date 2026-06
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-01