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NOT YET RECRUITING
NCT07617181
NA

Probiotics Supplementation for Neurodevelopment in Preterm Infants

Sponsor: Fudan University

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

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