A Phase 2 interventional study of tauroursodeoxycholic acid (TUDCA) and Placebo in Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development, sponsored by Peking University First Hospital. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Peking University First Hospital · Phase 2, Interventional, and Prevention
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.
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.
Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
High-risk mother-infant dyads randomized to this arm will receive maternal oral tauroursodeoxycholic acid (TUDCA) during the early postpartum period in addition to standard postpartum care and breastfeeding support.
Drug: tauroursodeoxycholic acid (TUDCA)
High-risk mother-infant dyads randomized to this arm will receive matching maternal oral placebo during the early postpartum period in addition to standard postpartum care and breastfeeding support.
Drug: Placebo
Maternal oral tauroursodeoxycholic acid administered according to the protocol-defined dose and schedule during the early postpartum period.
Also known as: TUDCA
Matching maternal oral placebo administered according to the same schedule as the experimental arm during the early postpartum period.
Also known as: Matching placebo
Incidence of maternal treatment-emergent adverse events
Number of lactating mothers with treatment-emergent adverse events, serious adverse events, treatment discontinuation, or clinically significant safety findings during the study period.
Time frame: Baseline to Day 28
Incidence of infant treatment-emergent adverse events
Number of infants with clinically significant adverse events, feeding intolerance, vomiting, diarrhea, jaundice requiring treatment, hospitalization, or other protocol-defined safety events during follow-up.
Time frame: Birth to Day 28
Change in breast milk bile acid hydrophobicity index
Change from baseline in breast milk bile acid hydrophobicity index measured by targeted liquid chromatography-mass spectrometry.
Time frame: Baseline to Day 7
Infant serum beta-hydroxybutyrate concentration
Infant serum beta-hydroxybutyrate concentration measured during follow-up.
Time frame: Day 7 and Day 14
Infant stool microbiome features
Changes in infant stool microbiome composition and predefined microbial features during follow-up.
Time frame: Day 7 and Day 14
Breast milk bile acid composition
Breast milk bile acid composition measured using targeted metabolomic profiling.
Time frame: Baseline, Day 7, and Day 14
Early infant neurodevelopmental screening score
Exploratory early infant neurodevelopmental assessment using a protocol-defined developmental screening tool.
Time frame: 3 months after birth
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Peking University First Hospital