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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат tauroursodeoxycholic acid (TUDCA)
  Maternal oral tauroursodeoxycholic acid administered according to the protocol-defined dose and schedule during the early postpartum period.
• Препарат Placebo
  Matching maternal oral placebo administered according to the same schedule as the experimental arm during the early postpartum period.

Первичные конечные точки

• Incidence of maternal treatment-emergent adverse events [Срок оценки: Baseline to Day 28]
• Incidence of infant treatment-emergent adverse events [Срок оценки: Birth to Day 28]
• Change in breast milk bile acid hydrophobicity index [Срок оценки: Baseline to Day 7]

Вторичные конечные точки (4)

• Infant serum beta-hydroxybutyrate concentration [Срок оценки: Day 7 and Day 14]
• Infant stool microbiome features [Срок оценки: Day 7 and Day 14]
• Breast milk bile acid composition [Срок оценки: Baseline, Day 7, and Day 14]
• Early infant neurodevelopmental screening score [Срок оценки: 3 months after birth]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07517276 · PKUFH-MASLD-MILKHI-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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