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

Study Overview
=================
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.

Official Title
-----------------
Pilot Randomized Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal and Gastric Microbiome

Conditions
-----------------
Esophageal Adenocarcinoma, Barrett's Esophagus, Reflux Esophagitis

Intervention / Treatment
-----------------
* Drug: Chlorhexidine gluconate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibacterial mouthwash<br>Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days. | Drug: Chlorhexidine gluconate<br>* Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.<br>* Other names: Peridex;|
| No Intervention: No intervention<br>Subjects will be randomized to no intervention for 21 days. | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiome, Esophagus, Endoscopy, Mouthwash