Longitudinal Oral Microbiome Sampling for BE

Launched by COLUMBIA UNIVERSITY · Nov 12, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the oral microbiome, which is the collection of bacteria and other microorganisms in the mouth, to see how it may relate to Barrett's esophagus (BE). Barrett's esophagus is a condition where the cells in the esophagus change, often due to acid reflux, and can increase the risk of esophageal cancer. The study will involve collecting saliva samples from participants over time to identify patterns in the oral microbiome that could help in understanding BE better.

To be eligible for the trial, participants should be at least 18 years old and either scheduled for or have had an upper endoscopy (a procedure to examine the upper digestive system) in the past three years. Participants should also have evidence of Barrett's esophagus from their endoscopy results. The study is open to all genders and is currently recruiting participants. Those who join can expect to provide saliva samples during their visits, and this ongoing monitoring may help researchers learn more about the relationship between the oral microbiome and Barrett's esophagus. Importantly, participants with certain medical histories, such as previous cancers in the head, neck, or esophagus, may not be eligible for the trial.

Gender

ALL

Eligibility criteria

• 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