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Special formula may help malnourished infants with bile duct disease

NCT ID NCT06764082

Disease control Sponsor: Tongji Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a high-MCT (medium-chain triglyceride) formula given before and after Kasai surgery can improve growth and nutrition in infants with biliary atresia. Biliary atresia is a rare liver condition that blocks bile flow, leading to malnutrition. The trial will enroll 120 infants under 3 months old across multiple centers, comparing the special formula to standard feeding. The main goal is to see if the formula helps babies gain weight better.

What this could mean

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

Active substance
high MCT formula (special medical-purpose formula food with medium-chain triglycerides)
What this could lead to
If it works, this could improve growth and nutritional status in infants with biliary atresia after surgery, potentially leading to better long-term outcomes.
What could go wrong
This is an early-stage, open-label study with only 120 participants, so results may not be conclusive. The intervention is dietary, so benefits may be modest and not apply to all infants.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

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

Started

Feb 2025

Expected to finish

Dec 2028

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

1 day to 3 months

Sex

Anyone

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: * Infants under 3 months old; * Children clinically diagnosed with biliary atresia and in need of Kasai surgery; * The patient themselves, legal representative or guardian have signed the informed consent form and are willing to actively cooperate with treatment and follow-up. Exclusion Criteria: * Low birth weight infants or very low birth weight infants; * Complicated with life-threatening diseases of various organ systems; * Complicated with other severe digestive tract malformations or other diseases that may interfere with the treatment of the patient or the patient's compliance; * Patients who have participated in other clinical trials within the last month; * Any other conditions that the researcher deems unsuitable for participation in this trial.

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Conditions

The condition(s) this trial relates to.

biliary atresia Infant Nutrition Disorders nutritional disorder

As listed by the trial registrant

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

Biliary atresia Nutrition disorder, infant

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Tongji Hospital

    RECRUITING

    Wuhan, Hubei, 430030, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.