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Could a bile acid pill in breast milk protect babies from liver problems?

NCT ID NCT07517276

Disease control Sponsor: Peking University First Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a bile acid pill (TUDCA) to breastfeeding mothers with fatty liver disease can make their breast milk healthier for their babies. Eighty mother-infant pairs will be randomly assigned to receive TUDCA or a placebo for a short time after birth. The goal is to see if the treatment is safe and improves infant metabolism and development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tauroursodeoxycholic acid (TUDCA)
What this could lead to
If successful, this could point toward a safe way for mothers with MASLD to improve their breast milk composition and support healthier infant development.
What could go wrong
This is an early Phase 2 trial with only 80 participants, so results may not apply widely. The treatment is for mothers, not directly for infants, and safety or effectiveness may not be confirmed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic dysfunction-associated steatotic liver disease infant development

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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