WithdrawnNot Applicable

Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)

Stopped: Study never began enrolling. Study team left institution.

United States0Started 2023-12

Plain-language summary

A prospective observational study in infants with biliary atresia and controls to determine whether the composition of the intestinal microbiome is specific for biliary atresia will be conducted. The hypothesis of the study is "infants with biliary atresia have a unique microbiome signature at the time of diagnosis and changes in population dynamics occur during disease progression". The microbiome will be determined at diagnosis and at well-defined time points during the natural history of the disease.

Who can participate

Age range

1 Day – 2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age:
Birth to 5 months
. Disease state: Must meet either (a), (b), or (c) for eligibility.
. Signed informed consent/assent

Exclusion criteria

. Evidence of multi-organ system failure (e.g. combined liver and kidney failure)
. For subjects \< 5 months old, treatment with antibiotics prior to enrollment into study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in intestinal microbiome signature.

Timeframe: Through study completion, an average of 24 months.

Trial details

NCT IDNCT03890536

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-03

View on ClinicalTrials.gov More Biliary Atresia trials