The Microbiome, Bile Acids, and Notch in Barrett's Esophagus (BE)

Completed

Conditions studied: Barrett Esophagus, Esophageal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT05524844

Run by

Columbia University

People needed

54

Starts

2021-02-09

Expected to finish

2024-11-01

Last updated by the study team

2025-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States
• Weill Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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