The Microbiome, Bile Acids, and Notch in Barrett's Esophagus (BE)
Key facts
- Who runs it
- Columbia University
- Where
- New York, United StatesSee the 2 sites
- Trial code
- Status
- Completed
- People taking part
- 54 people enrolled
- Started
- 9 Feb 2021
- Ended
- 1 Nov 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- Sample Collection
- Endoscopy results
- Dietary questionnaire
- Record updated
- 11 May 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- History of head and neck cancer or esophageal or gastric cancer (except esophageal intramucosal adenocarcinoma)
- History of esophageal or gastric surgery
- All subjects:
Where in United States
- Columbia University Irving Medical CenterNew York, United StatesNo longer taking part
- Weill Cornell Medical CenterNew York, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Control
Non-BE controls undergoing endoscopy for any indication who are on stable dose Proton Pump Inhibitors for the past month.
Treatment: Sample Collection, Endoscopy results, and 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.
Treatment: Sample Collection, Endoscopy results, and Dietary questionnaire
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Role of the Microbiome and Notch Signaling in Esophageal Adenocarcinoma
- Record updated
- 11 May 2025