NCT07517276Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 1 Apr 2026
- Start date
- Apr 2026
- Primary completion date
- May 2026
- Lead sponsor
- Peking University First Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07517276
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From Apr 2026 to the primary completion date, May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of ursodeoxycholic acid, tauroursodeoxycholic acid, or another protocol-prohibited bile acid-modifying medication
Other illness
- Maternal chronic liver disease other than MASLD, decompensated liver disease, biliary obstruction, acute cholecystitis, or pancreatitis
- Maternal severe renal insufficiency or other clinically significant condition judged by the investigator to increase study risk
- Major congenital anomaly or infant condition requiring ongoing intensive care at enrollment
- Any condition that, in the investigator's judgment, makes the mother-infant dyad unsuitable for participation
Other
- Preterm infant less than 37 weeks of gestation or birth weight less than 2500 g
Who the study is looking for
- Lactating mother aged 18 to 45 years
- Within 72 hours after delivery at screening
- Intention to continue breastfeeding or providing expressed breast milk during the treatment period
- Maternal metabolic dysfunction-associated steatotic liver disease (MASLD) defined by protocol-specified clinical criteria
- Early postpartum breast milk sample meeting the predefined high-risk bile acid hydrophobicity index threshold
- Live-born infant considered clinically stable and eligible for enteral feeding
- Ability and willingness to provide written informed consent for maternal participation and infant-related study procedures
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.