Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome

Columbia University

Status

Completed

Conditions

Reflux Esophagitis

Esophageal Adenocarcinoma

Barrett's Esophagus

Treatments

Drug: Chlorhexidine gluconate

Study type

Interventional

Funder types

Other

Identifiers

NCT02513784

AAAP4553

Details and patient eligibility

About

This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome

Full description

Patients scheduled for upper endoscopy for clinical indications will be randomized to 3 weeks of either no treatment or use of twice daily chlorhexidine mouthwash leading up to the endoscopy. There will be 2-3 study visits, at Day 0 and Day 21, and for those subjects in the mouthwash arm, a final visit 1-2 weeks following the Day 21 visit. Subjects will be required to fast overnight prior to the visits on Days 0 and 21.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age >18
Scheduled for upper endoscopy for clinical indications
No allergy or other contraindication to chlorhexidine

Exclusion criteria

Use of proton pump inhibitors or H2 receptor antagonists within 1 month of enrollment. Acid suppressant medications raise the gastric pH and can dramatically alter the gastric and esophageal microbiome.
History of upper gastrointestinal cancer
History of histologically proven Barrett's esophagus
History of antireflux or bariatric surgery, or other gastric or esophageal surgery
Use of antimicrobial mouthwash within 1 month of enrollment
Use of antibiotics or immunosuppressant medications within 3 months of enrollment
Use of steroid inhalers or nasal sprays within 1 month of enrollment
HIV or other immunosuppressed states or conditions (e.g. active malignancy)
Pregnant or breast feeding
Inability to give informed consent