Clinical trial · Observational
The Microbiome, Bile Acids, and Notch in Barrett's Esophagus (BE)
The Role of the Microbiome and Notch Signaling in Esophageal Adenocarcinoma
- 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)
The purpose of this study is to prospectively collect and analyze clinical data and biospecimens from a cohort of 100 patients without BE (20), with non-dysplastic BE (40), or with BE and high grade dysplasia (HGD) or EAC (40). The investigators will enroll 80 patients scheduled for upper endoscopy for clinical purposes, with a history of histologically confirmed BE (2 cm length); 40 with no history of dysplasia, and 40 with HGD or EAC. The investigators will also enroll 20 non-BE controls undergoing endoscopy for any indication who are on stable dose proton-pump inhibitors (PPI) for the past month. PPI therapy is standard of care for BE patients.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary questionnaire | Other | — | UNRESOLVED |
| Endoscopy results | Other | — | UNRESOLVED |
| Sample Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control
- description
- Non-BE controls undergoing endoscopy for any indication who are on stable dose Proton Pump Inhibitors for the past month.
- interventionNames
- Other: Sample Collection
- Other: Endoscopy results
- Other: Dietary questionnaire
- label
- Barrett's Esophagus
- description
- Patients scheduled for upper endoscopy for clinical purposes, with a history of histologically confirmed Barrett's esophagus (2 cm length); 40 with no history of dysplasia, and 40 with high grade dysplasia or esophageal adenocarcinoma.
- interventionNames
- Other: Sample Collection
- Other: Endoscopy results
- Other: Dietary questionnaire
Primary outcomes (2)
- measure
- Concentration of Deoxycholic Acid (DCA)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All subjects: * Scheduled for an upper endoscopy * Taking stable dose of a proton pump inhibitor at least once daily for 1 months prior to enrollment * Eighteen years of age or older * Able to give informed consent Barrett's esophagus subjects only: * Histologically confirmed BE (defined as endoscopically- suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies) * Maximal BE length ≥ 2 cm (Prague criteria: any C, M≥2) Exclusion Criteria: All subjects: * History of head and neck cancer or esophageal or gastric cancer (except esophageal intramucosal adenocarcinoma) * History of esophageal or gastric surgery * Use of antibiotics or immunosuppressants within 1 month prior to endoscopy Barrett's esophagus subjects only: • History of prior endoscopic therapy for BE, except a history of prior endoscopic mucosal resection (EMR) of focal lesions withoutsubsequent ablative therapy is permitted
References
Publications (0)
Data not yet available