NCT07517276

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

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Maternal Oral TUDCA in High-Risk Lactating Mother-Infant Dyads Identified by Early Postpartum Breast Milk Bile Acid Hydrophobicity Index

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a single-center, randomized, double-blind, placebo-controlled Phase 2 interventional study conducted in lactating mother-infant dyads. Mothers with metabolic dysfunction-associated steatotic liver disease (MASLD) will be screened in the early postpartum period. Breast milk samples collected within the first days after delivery will be analyzed to determine bile acid hydrophobicity index. Dyads meeting a predefined high-risk threshold will be enrolled and randomized in a 1:1 ratio to receive either maternal oral tauroursodeoxycholic acid (TUDCA) or matching placebo. Study treatment will be administered during the early postpartum period for a defined duration. The primary endpoints include maternal and infant safety and tolerability, as well as changes in breast milk bile acid hydrophobicity index. Secondary endpoints include infant serum beta-hydroxybutyrate levels and gut microbiome features. Exploratory endpoints include early neurodevelopmental outcomes during follow-up. This study aims to provide proof-of-concept evidence for a mechanism-based intervention targeting maternal milk composition to influence early-life metabolic and developmental pathways.

Conditions

• Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development

Interventions

Type	Name	Description
DRUG	tauroursodeoxycholic acid (TUDCA)	Maternal oral tauroursodeoxycholic acid administered according to the protocol-defined dose and schedule during the early postpartum period.
DRUG	Placebo	Matching maternal oral placebo administered according to the same schedule as the experimental arm during the early postpartum period.

Timeline

• Start date: 2026-04-02
• Primary completion: 2026-05-30
• Completion: 2026-07-30
• First posted: 2026-04-08
• Last updated: 2026-04-08