Longitudinal Oral Microbiome Sampling for BE

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Columbia University
Study ID
NCT05133102
Status
Recruiting
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Conditions

  • Barrett Esophagus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Sample collection — OTHER
    Collection of saliva sample

Study Details

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 Dates

Start date
Mar 19, 2021
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
275 participants (estimated)

Arms

  • Arm: Control
    Patients who have undergone an endoscopy within the last three years and have never been diagnosed with Barrett's esophagus.
  • Arm: Barrett's Esophagus
    Patients who have undergone an endoscopy within the last three years and have histologically confirmed Barrett's esophagus. BE segment must be M\>1cm, and has not be treated with endoscopic eradication therapy (focal mucosal resection without subsequent eradication therapy is allowed).

Primary Outcome Measure

Performance characteristics of a microbiome-based classifier with repeated sampling [ Time Frame: 2 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Joel H. Rubenstein, MD
[email protected]
Amy Liu
[email protected]
Columbia University Irving Medical CenterNew YorkNew York10032
Julian Abrams, MD
[email protected]
212-305-1909

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University of Michigan· Ann Arbor, MIColumbia University Irving Medical Center· New York, NY

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