Clinical trial · Observational
Longitudinal Oral Microbiome Sampling for BE
Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus
NCT05133102CI-TRIAL-00111243recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sample collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control
- description
- Patients who have undergone an endoscopy within the last three years and have never been diagnosed with Barrett's esophagus.
- interventionNames
- Other: Sample collection
- label
- Barrett's Esophagus
- description
- Patients who have undergone an endoscopy within the last three years and have histologically confirmed Barrett's esophagus. BE segment must be M\>1cm, and has not be treated with endoscopic eradication therapy (focal mucosal resection without subsequent eradication therapy is allowed).
- interventionNames
- Other: Sample collection
Primary outcomes (2)
- measure
- Performance characteristics of a microbiome-based classifier with repeated sampling
- timeFrame
- 2 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.