TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index (NCT07517276) | Clinical Trial Compass
Not Yet RecruitingPhase 2
TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index
80 participantsStarted 2026-04-02
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Maternal chronic liver disease other than MASLD, decompensated liver disease, biliary obstruction, acute cholecystitis, or pancreatitis
* Current use of ursodeoxycholic acid, tauroursodeoxycholic acid, or another protocol-prohibited bile acid-modifying medication
* Maternal severe renal insufficiency or other clinically significant condition judged by the investigator to increase study risk
* Preterm infant less than 37 weeks of gestation or birth weight less than 2500 g
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial that hasn't started recruiting yet — what does that mean for how much is already known about the safety of TUDCA for breastfeeding mothers and their infants, and should I wait until more data is available before considering it?
2The trial measures treatment-emergent adverse events in both mother and infant — since my baby would indirectly be exposed through breast milk, what risks should I be aware of and how would my infant be monitored if something unexpected happened?
3The trial involves a bile acid hydrophobicity index measured from breast milk — can you explain what that test showed about my own milk, and what it means for my baby's health if I don't participate in this trial?
4Since the trial is specifically for mothers with metabolic dysfunction-associated steatotic liver disease, how does my current liver health affect whether this study would even be relevant to my situation, and are there standard treatments I should try first?
5Because the trial isn't recruiting yet, are there other ways I could address my liver condition now that wouldn't prevent me from joining this study later if I decide I want to?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of maternal treatment-emergent adverse events
Timeframe: Baseline to Day 28
2
Incidence of infant treatment-emergent adverse events
Timeframe: Birth to Day 28
3
Change in breast milk bile acid hydrophobicity index