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Dietary Pattern Intervention for Neurodevelopment in Preterm Infants
Sponsor: Fudan University
Summary
The purpose of this randomized controlled trial is to evaluate the effect of a structured, high-prebiotic dietary pattern on the neurodevelopmental outcomes of preterm infants. The intervention lasts for 6 months and aims to promote the growth of endogenous beneficial gut bacteria through targeted complementary feeding. 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 and tryptophan metabolites), and systemic inflammatory markers.
Official title: Effect of Gut Microbiota Remodeling Via Structured Prebiotic Dietary Pattern on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
6 Months - 6 Months
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2026-07-01
Completion Date
2027-12-31
Last Updated
2026-07-14
Healthy Volunteers
No
Interventions
Structured High-Prebiotic Dietary Pattern
Individualized, face-to-face guidance and tailored recipes provided by a registered dietitian, focusing on the scientific introduction of prebiotic-rich complementary foods to promote endogenous beneficial gut bacteria over a 6-month period.
Locations (1)
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China