Recruiting

Oral Microbiome

Sponsor:

Columbia University

Code:

NCT05133102

Conditions

Barrett Esophagus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sample collection

Study Details

Brief summary:

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.

Conditions

Barrett Esophagus

Study ID

NCT05133102

Start date

Mar 19, 2021

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

275 participants

Anticipated

Interventions and Outcome Measures

Arms

Control

Patients who have undergone an endoscopy within the last three years and have never been diagnosed with Barrett's esophagus.

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).

Interventions

Sample collection

Collection of saliva sample

Primary outcome measure

  • Performance characteristics of a microbiome-based classifier with repeated sampling [ Time Frame: 2 months ]
  • Intra-class correlation coefficients (ICC) by BE status [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Julian Abrams, MD

212-305-1909ja660@cumc.columbia.edu

Katharine Boyce, RN

kb3217@cumc.columbia.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Joel H. Rubenstein, MD

jhr@med.umich.edu

Amy Liu

Liuyalie@med.umich.edu

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Julian Abrams, MD

212-305-1909ja660@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • Saliva
  • Sampling
  • Oral Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-05-12.