Could a common bile acid pill cut the number of procedures for a precancerous esophagus?
NCT ID NCT07756710
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This pilot study tests whether ursodeoxycholic acid (UDCA), a medication already used for liver and gallbladder conditions, can improve healing of the esophagus after endoscopic treatment for Barrett's esophagus with dysplasia. The study follows about 15 patients who take UDCA during their treatment to see if it helps normal tissue regrow faster and reduces the number of procedures needed. If successful, this approach could make treatment safer, cheaper, and more accessible for people at risk of esophageal cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ursodeoxycholic acid (UDCA), an FDA-approved medication for certain liver and gallbladder conditions
- What this could lead to
- If UDCA improves healing after endoscopic treatment, it could reduce the number of procedures needed, lowering costs and risks for people with Barrett's esophagus.
- What could go wrong
- This is a small pilot study, so results may not be conclusive. UDCA may not improve healing, and the study does not yet prove long-term benefits.
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
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
Patients with Barrett's esophagus (BE) and low-grade dysplasia (LGD), high-grade dysplasia (HGD), or intramucosal adenocarcinoma undergoing endoscopic eradication therapy who are taking ursodeoxycholic acid (UDCA).
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Barrett's esophagus, defined as endoscopic evidence of BE with esophageal biopsies showing intestinal metaplasia. * Pre-treatment histology of low- or high-grade dysplasia or intramucosal adenocarcinoma. * BE length ≥2 cm (Prague classification: any C, M≥2). The decision was made to exclude patients with BE segments shorter than 2 cm, as assessment of % neosquamous regrowth in shorter segments is likely neither reliable nor highly reproducible. * Prior endoscopic resection of focal lesions is permitted. Endoscopic resection of nodular lesions must be performed prior to initiating ablation therapy. * Taking UDCA 13-15 mg/kg divided into twice daily dosing. * Either one of the following: * No prior endoscopic ablation therapy, OR * Single prior ablation treatment and \<50% response (i.e. \<50% neosquamous replacement of original BE segment) and ≥2 cm of residual BE Exclusion Criteria: * Allergy, hypersensitivity, or intolerance to UDCA. * Age ≤18 years. * Pregnant or planning to get pregnant during the study period. * Unable to give informed consent. * Known acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula (contraindications to UDCA use).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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