The Microbiome, Bile Acids, and Notch in Barrett's Esophagus (BE)

NCT05524844 | Completed

• 2 other identifiers: AAAT2456R01CA255298
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

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

Barrett Esophagus; Esophageal Adenocarcinoma

Keywords

Saliva; Microbiome

Outcome Measures

Primary Outcomes (2)

• Concentration of Deoxycholic Acid (DCA)

  To determine whether refluxate deoxycholic acid (DCA) is associated with increased Notch signaling in the development of esophageal adenocarcinoma (EAC), the investigators will calculate Pearson's correlation coefficients to assess within individual correlations between DCA and NOTCH3 gene expression.

  2 years

• Correlation between Enterobacteriaceae (from 16S) and NOTCH3 expression in BE tissue.

  The within-individual correlation will be calculated.

  2 years

Study Arms (2)

Control

Non-BE controls undergoing endoscopy for any indication who are on stable dose Proton Pump Inhibitors for the past month.

Other: Sample Collection; Other: Endoscopy results; Other: Dietary questionnaire

Barrett's Esophagus

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.

Other: Sample Collection; Other: Endoscopy results; Other: Dietary questionnaire

Interventions

Sample Collection OTHER

Saliva, gastric aspirate, and esophageal brushings and biopsies.

Barrett's Esophagus; Control

Endoscopy results OTHER

Results from standard of care endoscopy (scheduled separate of study)

Barrett's Esophagus; Control

Dietary questionnaire OTHER

Diet History Questionnaire (II)

Barrett's Esophagus; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be based on the population of BE and EAC as well as the demographics of those who undergo upper endoscopy for other indications (the control population) at Columbia and Cornell, together with data drawn from numerous prior studies in our BE population.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Weill Medical College of Cornell University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Esophageal brushings Esophageal biopsies Gastric aspirate

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Julian Abrams, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: February 9, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)