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

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 Barrett Esophagus 🦠 Esophageal Adenocarcinoma

🗓️ Study Start (Actual) 9 February 2021

🗓️ Primary Completion (Estimated) April 2025

✅ Study Completion (Estimated) December 2025

👥 Enrollment (Estimated) 100

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 New York, New York, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 30 August 2022
First Submitted that Met QC Criteria 30 August 2022
First Posted 1 September 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 3 June 2024
Last Update Posted 4 June 2024
Last Verified June 2024