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

Sponsor

Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT02513784

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Adenocarcinoma Barrett's Esophagus Reflux Esophagitis	Drug: Chlorhexidine gluconate	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antibacterial mouthwash Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.	Drug: Chlorhexidine gluconate Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth. Other Names: Peridex
No Intervention: No intervention Subjects will be randomized to no intervention for 21 days.

Arm

Intervention/Treatment

Experimental: Antibacterial mouthwash

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

Drug: Chlorhexidine gluconate

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

Other Names:

Peridex

No Intervention: No intervention

Subjects will be randomized to no intervention for 21 days.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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