Longitudinal Oral Microbiome Sampling for BE

Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05133102

Enrollment

275

Registered

2021-11-24

Start date

2021-03-19

Completion date

2027-08-01

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett Esophagus

Keywords

Saliva, Sampling, Oral Microbiome

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.

Detailed description

Saliva collection is non-invasive and can be performed in clinical and non-clinical settings. As such, saliva testing is a highly attractive method for diagnosing and/or monitoring disease. The investigators previously showed that the bacterial make-up ("microbiome") of saliva is highly distinct in patients with and without Barrett's esophagus (BE), a precursor to esophageal cancer that normally can only be diagnosed by undergoing an upper endoscopy. While the microbiome of saliva is felt to be relatively stable over time, it is unclear whether a microbiome signature for Barrett's esophagus is reproducible within individuals. Also, repeated testing of saliva may improve the ability to diagnose Barrett's esophagus.

Interventions

OTHERSample collection

Collection of saliva sample

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Performance characteristics of a microbiome-based classifier with repeated sampling	2 months	Using a classifier developed from 16S rRNA gene sequencing data, the investigators will calculate the area under the receiver operating curve (AUROC) and associated 95% confidence interval for a classifier with three repeated measures per subject.
Intra-class correlation coefficients (ICC) by BE status	2 months	This will be measured to determine the degree of consistency of a microbiome-based classifier for each individual's salivary microbiome assessments (three total per subject).

Countries

United States

Contacts

CONTACTJulian Abrams, MD

ja660@cumc.columbia.edu212-305-1909

CONTACTKatharine Boyce, RN

kb3217@cumc.columbia.edu

PRINCIPAL_INVESTIGATORJulian Abrams, MD

Columbia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026