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

U.S., April 9 -- ClinicalTrials.gov registry received information related to the study (NCT07517276) titled 'TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index' on April 01.

Brief 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 mate...