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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Esophageal Adenocarcinoma Barrett's Esophagus Reflux Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antibacterial mouthwash

Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.

Group Type EXPERIMENTAL

Chlorhexidine gluconate

Intervention Type DRUG

Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.

No intervention

Subjects will be randomized to no intervention for 21 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chlorhexidine gluconate

Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.

Intervention Type DRUG

Other Intervention Names

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Peridex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes