Longitudinal Oral Microbiome Sampling for BE

Recruiting now

Conditions studied: Barrett Esophagus

In brief

This is a longitudinal cohort study to assess the impact of repeated sampling of an oral microbiome signature for Barrett's esophagus (BE). Potential participants will be identified through chart review of patients who have had an endoscopy in the past three years.

Key facts

Study ID

NCT05133102

Run by

Columbia University

People needed

275

Starts

2021-03-19

Expected to finish

2027-08-01

Last updated by the study team

2026-05-12

Who can join

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

You may qualify if…

• Scheduled for an upper endoscopy or had upper endoscopy within past three years
• Eighteen years of age or older
• Capable of producing a saliva sample
• Able to give informed consent
• For BE patients only: Endoscopic evidence of Barrett's esophagus (at least 1 cm maximal BE length; i.e. Prague classification: any C, M≥1), and intestinal metaplasia present on esophageal biopsies

You may not qualify if…

• History of head and neck cancer or esophageal squamous cell or gastric cancer
• History of esophageal or gastric surgery
• Scheduled to undergo colonoscopy on the day of initial saliva collection
• Scheduled only for Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopy ultrasound (EUS) without accompanying standard upper endoscopy on the day of initial saliva collection
• For BE patients only: History of prior endoscopic therapy for BE except a history of prior Endoscopic mucosal resection (EMR) of focal lesions without subsequent ablative therapy is permitted

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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