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

Not Applicable

Completed

• Conditions: Esophageal Adenocarcinoma; Barrett's Esophagus; Reflux Esophagitis
• Interventions: Drug: Chlorhexidine gluconate

• Registration Number: NCT02513784
• Lead Sponsor: Columbia University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-07-31
• Study Start: 2015-08
• Study First Posted: 2015-08-03
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Disposition First Submitted: 2019-07-26
• Disposition First Submitted QC: 2019-07-26
• Disposition First Posted: 2019-08-02
• Results First Submitted: 2021-06-11
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-27
• Last Update Submitted: 2022-08-27
• Results First Posted: 2022-09-22
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibacterial mouthwash	Chlorhexidine gluconate	Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.

Primary Outcome Measures

Name	Time	Method
Reduction of F. Nucleatum in Saliva	21 days	Within individual change in relative abundance of F nucleatum in oral samples
Difference in Esophageal F. Nucleatum Between Experimental Group and no Intervention Group	21 days	Comparison of relative abundance of esophageal F. nucleatum in the mouthwash group vs. the no intervention group.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States