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Observational Study of Oral Microbiome for Barrett's Esophagus

This observational study is looking at how repeated saliva samples can help detect Barrett's esophagus (BE), a condition that can lead to esophageal cancer. Researchers want to see if the bacteria in your saliva ("microbiome") can reliably show if you have BE, which is usually found through an upper endoscopy. They will collect saliva samples to see if a specific microbiome pattern for BE stays the same over time within individuals. The study aims to enroll 275 participants who are at least 18 years old and have either had an upper endoscopy recently or are scheduled for one. Success will be measured by how well the microbiome-based test performs with repeated sampling and how consistent the results are for people with and without BE.

Study design
This is an observational study with a planned enrollment of 275 participants. It is designed to look at changes over time rather than testing a specific treatment.
What's involved
You would provide saliva samples, and the study will assess the results at 2 months. The study does not specify how many samples or visits are involved.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 2 months, suggesting a follow-up period of at least two months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05133102

Longitudinal Oral Microbiome Sampling for BE

Recruiting
Not specifiedAges 18+Observational
Columbia University
~275 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Sample collection

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Performance characteristics of a microbiome-based classifier with repeated sampling
Measured over 2 months
+1 more outcome measured

Conditions

Barrett Esophagus

Explore related trials

Barrett Esophagus

Where it's being run

2 sites across 2 states
Michigan1
New York1

Study leadership

  • Julian Abrams, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Julian Abrams, MD
[email protected]
212-305-1909
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Performance characteristics of a microbiome-based classifier with repeated sampling2 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 status2 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).