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

NCT05524844 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2025-05-11

No results posted yet for this study

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

Interventions

OTHER

Sample Collection

Saliva, gastric aspirate, and esophageal brushings and biopsies.

OTHER

Endoscopy results

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

OTHER

Dietary questionnaire

Diet History Questionnaire (II)

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Julian Abrams, MD · Columbia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05524844 on ClinicalTrials.gov