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Could daily antibiotics shield babies from Post-Surgery infections?

NCT ID NCT05925309

Disease control Sponsor: Children's Hospital of Fudan University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving oral antibiotics after Kasai surgery can prevent cholangitis, a serious bile duct infection, in infants with biliary atresia. About 356 babies will be randomly assigned to receive either preventive antibiotics or standard care, and they will be followed for two years. The goal is to see if the antibiotics reduce infection rates without causing major side effects.

What this could mean

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

Active substance
oral antibiotics (prophylactic)
What this could lead to
If it works, this could show that preventive antibiotics lower the risk of serious bile duct infections after Kasai surgery, improving outcomes for babies with biliary atresia.
What could go wrong
This is an early-stage trial with no phase designation, and the results may not apply to all patients. Antibiotics can cause side effects like diarrhea or resistance.

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 356 people

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

Started

Jul 2023

Expected to finish

Dec 2029

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

14 to 90 days

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: * Patients whose age of operation is 14-90 d. Sex and race are not restricted; * Patients who are born with gestational age older than 36 weeks; * Patients whose body weight before operation \> 2 kg; * Patients diagnosed of type-III BA and underwent KP in Children's Hospital of Fudan University; * The type-III BA diagnosis is based on cholangiography or operation; * Patients whose histological features of liver biopsies are reported. HE staining and Masson staining are required, and edema, inflammation, fibrosis, and hyperplasia of intrahepatic bile duct should be reported; * Patients who are not allergic to postoperative medications; * Patients who haven't accepted other antibiotic or probiotic therapy. Exclusion Criteria: * Patients with cholestasis of non-BA disease; * Patients who have undergone KP at other institutions; * Patients whose pathohistological diagnosis is in doubt; * Patients who undergo liver transplantation immediately after KP; * Patients with other liver diseases or severe complications (e.g., severe pulmonary hypertension, renal failure, intracranial hemorrhage, etc.) requiring surgical intervention or other medical therapy; * Patients with severe cardiac, renal, or central nerve system malformations (e.g., tetralogy of Fallot, transposition of the great arteries, cerebral dysplasia, etc.) and have poor prognosis; * Patients judged by the researchers that they can not comply with the study requirements.

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Conditions

The condition(s) this trial relates to.

biliary atresia cholangitis prevention target

As listed by the trial registrant

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

Anti-bacterial agents Biliary atresia Cholangitis

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

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Contacts and locations

Locations

  • Children's Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 201102, China

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