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Diaper photos may spot hidden liver disease in babies

NCT ID NCT07697872

Diagnosis Sponsor: Birmingham Women's and Children's NHS Foundation Trust Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study explores whether a computer program can learn to spot signs of cholestasis—a liver condition where bile flow is blocked—by analyzing photos of dirty diapers taken by parents. Researchers will collect images from thousands of infants, both healthy and those with suspected liver issues, to see if the algorithm can accurately tell the difference. If it works, this simple, non-invasive approach could lead to earlier diagnosis and better outcomes for babies with serious liver diseases like biliary atresia.

What this could mean

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

Active substance
machine-learning algorithm analyzing parent-provided stool images
What this could lead to
If successful, this could enable early, non-invasive screening for liver conditions in newborns, potentially preventing long-term damage through timely treatment.
What could go wrong
The algorithm may not be accurate enough in real-world settings, and the study is observational, so it does not test treatment outcomes. Parent participation and image quality could also affect results.

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.

Participants

About 5,350 people

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

Started

Apr 2025

Expected to finish

Sep 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.

Who is studied

Recruited from hospitals enrolled in the study.

Ages

Up to 11 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: All Arms: Informed Consent: Parents/guardians can give informed consent for their child's participation in the study and can understand written English. 1. Retrospective Cholestasis Arm: All infants, of any gestation, male and female who were referred to Birmingham Liver Unit from any hospital for investigation of suspected cholestasis within the previous 10 years before the study launch. At the time of the referral to Birmingham Liver Unit the children were under the age of 6 months and the children were referred before the start date of the study. 2. Prospective Cholestasis Arm: All infants, of any gestation, male and female who were referred to Birmingham Liver Unit from any hospital for investigation of suspected cholestasis after the study launch. At the time of the referral to Birmingham Liver Unit the children were under the age of 6 months. 3. Prospective Non-Cholestasis Arm All infants, of any gestation, male and female \& aged less than 28 days, not thought to be cholestatic at the time of recruitment \& with the birth registered at any of the participating hospital trusts. Exclusion Criteria: If the inclusion criteria as outlined are met, there is no exclusion criteria.

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Conditions

The condition(s) this trial relates to.

biliary atresia cholestasis

As listed by the trial registrant

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

Biliary atresia Cholestasis in newborn Neonatal cholestasis

How to take part

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  1. The places running it

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  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

  • Birmingham Women's and Children's NHS Foundation Trust

    RECRUITING

    Birmingham, United Kingdom

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