Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome
Status: | Completed |
---|---|
Conditions: | Cancer, Gastroesophageal Reflux Disease , Gastrointestinal, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/31/2018 |
Start Date: | August 2015 |
End Date: | December 2017 |
Pilot Randomized Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal and Gastric Microbiome
This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine
mouthwash can alter the esophageal and gastric cardia microbiome
mouthwash can alter the esophageal and gastric cardia microbiome
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.
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.
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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Julian A. Abrams, MD
Phone: 212-304-5595
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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