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

NCT07517276 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

  • Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development

Interventions

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.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Yuhang Zhang, MD, PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-02
Primary Completion
2026-05-30
Completion
2026-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07517276 on ClinicalTrials.gov