The Microbiome, Bile Acids, and Notch in Barrett's Esophagus (BE) (NCT05524844) | Clinical Trial Compass
CompletedNot Applicable
The Microbiome, Bile Acids, and Notch in Barrett's Esophagus (BE)
United States54 participantsStarted 2021-02-09
Plain-language summary
The purpose of this study is to prospectively collect and analyze clinical data and biospecimens from a cohort of 100 patients without BE (20), with non-dysplastic BE (40), or with BE and high grade dysplasia (HGD) or EAC (40). The investigators will enroll 80 patients scheduled for upper endoscopy for clinical purposes, with a history of histologically confirmed BE (2 cm length); 40 with no history of dysplasia, and 40 with HGD or EAC. The investigators will also enroll 20 non-BE controls undergoing endoscopy for any indication who are on stable dose proton-pump inhibitors (PPI) for the past month. PPI therapy is standard of care for BE patients.
Who can participate
Age range
18 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:
All subjects:
* Scheduled for an upper endoscopy
* Taking stable dose of a proton pump inhibitor at least once daily for 1 months prior to enrollment
* Eighteen years of age or older
* Able to give informed consent
Barrett's esophagus subjects only:
* Histologically confirmed BE (defined as endoscopically- suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies)
* Maximal BE length ≥ 2 cm (Prague criteria: any C, M≥2)
Exclusion Criteria:
All subjects:
* History of head and neck cancer or esophageal or gastric cancer (except esophageal intramucosal adenocarcinoma)
* History of esophageal or gastric surgery
* Use of antibiotics or immunosuppressants within 1 month prior to endoscopy
Barrett's esophagus subjects only:
• History of prior endoscopic therapy for BE, except a history of prior endoscopic mucosal resection (EMR) of focal lesions withoutsubsequent ablative therapy is permitted
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
1
Concentration of Deoxycholic Acid (DCA)
Timeframe: 2 years
2
Correlation between Enterobacteriaceae (from 16S) and NOTCH3 expression in BE tissue.