TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index

This is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial in mother-infant dyads. The study aims to evaluate the safety, tolerability, and biological effects of maternal oral tauroursodeoxycholic acid (TUDCA) in lactating mothers with metabolic dysfunction-associated steatotic liver disease (MASLD). Eligible mother-infant dyads will be screened in the early postpartum period using breast milk bile acid hydrophobicity index. Dyads identified as high risk will be randomized 1:1 to maternal oral TUDCA or placebo. The primary objectives are to assess maternal and infant safety and to evaluate changes in breast milk bile acid hydrophobicity index. Secondary objectives include assessment of infant ketone-related metabolic biomarkers and gut microbiome features. Exploratory outcomes include early infant neurodevelopment during follow-up.

NCT Number	NCT07517276
Lead Sponsor	Peking University First Hospital
Conditions	Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development
Enrollment	80 participants
Start Date	2026-04-02
Primary Completion	2026-05-30 (estimated)
Study Completion	2026-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-08