Clinical trial · Observational
The Microenvironment in Barrett's Esophagus
Application of the Microbiome and Microenvironment to Novel Non-Endoscopic Screening and Surveillance in Barrett's Esophagus
- 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 study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest risk for EAC. To accomplish this the investigators will enroll 100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled volatile organic compounds), and tethered capsule sponge sampling (methylated DNA markers). The study will evaluate these novel tests in combination with clinical and anthropometric factors to describe an optimal strategy for BE screening and monitoring.
Conditions
Conditions (2)
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 | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic nose device | Device | — | UNRESOLVED |
| Tethered capsule sponge | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Barrett's esophagus
- description
- Barrett's esophagus, without or with dysplasia or adenocarcnoma
- interventionNames
- Device: Tethered capsule sponge
- Device: Electronic nose device
- label
- Controls
- description
- Non-BE endoscopic controls
- interventionNames
- Device: Tethered capsule sponge
- Device: Electronic nose device
Primary outcomes (1)
- measure
- Oral and esophageal 16S rRNA gene sequencing
- timeFrame
- 1 day
- description
- Oral and esophageal microbiome
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: (for BE patients) * History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies * BE length M≥2 * Taking proton pump inhibitors at least once daily for 3 months prior to enrollment * Age ≥18 Exclusion Criteria: * History of gastric cancer or esophageal squamous cell cancer * History of gastric or esophageal surgery * Use of antibiotics or systemic immunosuppressants within three months prior to the date of endoscopy (intranasal and inhaled steroids are allowed) * Known untreated esophageal stricture or uninvestigated dysphagia * Inability to give informed consent * (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 (1)
- DERIVEDIyer PG, Slettedahl SW, Mahoney DW, Giakoumopoulos M, Olson MC, Krockenberger M, Taylor WR, Foote P, Berger C, Leggett C, Wu TT, Antpack E, Falk GW, Ginsberg GG, Abrams JA, Lightdale CJ, Ramirez F, Kahn A, Wolfsen H, Konda V, Trindade AJ, Kisiel JB. Algorithm Training and Testing for a Nonendoscopic Barrett's Esophagus Detection Test in Prospective Multicenter Cohorts. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1596-1604.e4. doi: 10.1016/j.cgh.2024.03.003. Epub 2024 Mar 19. PMID 38513982