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NCT Number: NCT05133102

Longitudinal Oral Microbiome Sampling for BE

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample collection

Other

Collection of saliva sample

Primary outcomes

  1. Performance characteristics of a microbiome-based classifier with repeated sampling

    Time frame: 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.

  2. Intra-class correlation coefficients (ICC) by BE status

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Julian Abrams, MD

CONTACT

[email protected]

212-305-1909

Katharine Boyce, RN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Michigan

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2021
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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