N/A
N=20
Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome
Esophageal Adenocarcinoma · Barrett's Esophagus · Reflux Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT02513784 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Reduction of F. Nucleatum in Saliva
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chlorhexidine gluconate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of F. Nucleatum in Saliva |
— | — |
| PRIMARY Difference in Esophageal F. Nucleatum Between Experimental Group and no Intervention Group |
— | — |
Summary
This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome
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
Data sourced from ClinicalTrials.gov (NCT02513784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.