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Probiotics Supplementation for Neurodevelopment in Preterm Infants
Sponsor: Fudan University
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.
Official title: Effect of Gut Microbiota Remodeling Via Probiotics Supplementation on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
23 Weeks - 25 Weeks
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2026-06
Completion Date
2027-12
Last Updated
2026-06-01
Healthy Volunteers
No
Interventions
Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG)
Daily oral administration of a probiotic mixture containing Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG at a dose of 3 x 10\^9 CFU/day for 6 months.
Locations (1)
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China