Back to resultsTrial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome (Mouthwash)
Primary Purpose
Esophageal Adenocarcinoma, Barrett's Esophagus, Reflux Esophagitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine gluconate
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Adenocarcinoma focused on measuring Microbiome, Esophagus, Endoscopy, Mouthwash
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
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Antibacterial mouthwash
No intervention
Arm Description
Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.
Subjects will be randomized to no intervention for 21 days.
Outcomes
Primary Outcome Measures
Reduction of F. Nucleatum in Saliva
Within individual change in relative abundance of F nucleatum in oral samples
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02513784
Brief Title
Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome
Acronym
Mouthwash
Official Title
Pilot Randomized Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal and Gastric Microbiome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Adenocarcinoma, Barrett's Esophagus, Reflux Esophagitis
Keywords
Microbiome, Esophagus, Endoscopy, Mouthwash
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antibacterial mouthwash
Arm Type
Experimental
Arm Description
Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Subjects will be randomized to no intervention for 21 days.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
Peridex
Intervention Description
Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.
Primary Outcome Measure Information:
Title
Reduction of F. Nucleatum in Saliva
Description
Within individual change in relative abundance of F nucleatum in oral samples
Time Frame
21 days
Title
Difference in Esophageal F. Nucleatum Between Experimental Group and no Intervention Group
Description
Comparison of relative abundance of esophageal F. nucleatum in the mouthwash group vs. the no intervention group.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian A. Abrams, MD, MS
Organizational Affiliation
Assistant Professor of Medicine and Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33512805
Citation
Annavajhala MK, May M, Compres G, Freedberg DE, Graham R, Stump S, Que J, Korem T, Uhlemann AC, Abrams JA. Relationship of the Esophageal Microbiome and Tissue Gene Expression and Links to the Oral Microbiome: A Randomized Clinical Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00235. doi: 10.14309/ctg.0000000000000235.
Results Reference
derived
Links:
URL
https://journals.lww.com/ctg/Fulltext/2020/12000/Relationship_of_the_Esophageal_Microbiome_and.13.aspx
Description
Clinical and Translational Gastroenterology: December 2020 - Volume 11 - Issue 12
Learn more about this trial
Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome
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