NCT05133102

Longitudinal Oral Microbiome Sampling for BE

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 275 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
OTHER	Sample collection	Collection of saliva sample

Timeline

• Start date: 2021-03-19
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2021-11-24
• Last updated: 2025-04-20

Locations

2 sites across 1 country: United States