Barrett's Esophagus, Esophageal Adenocarcinoma, Reflux Esophagitis
Conditions
Keywords
Microbiome, Esophagus, Endoscopy, Mouthwash
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.
Interventions
DRUGChlorhexidine gluconate
Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antibacterial Mouthwash Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.
Chlorhexidine gluconate: Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth. | 10 |
| No Intervention Subjects will be randomized to no intervention for 21 days. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Antibacterial Mouthwash | No Intervention | Total |
|---|---|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 12.9 | 51.2 years STANDARD_DEVIATION 15.5 | 52.4 years STANDARD_DEVIATION 13.9 |
| Aspirin Use | 4 Participants | 4 Participants | 8 Participants |
| Body Mass Index | 29.2 kg/m^2 STANDARD_DEVIATION 6 | 31.2 kg/m^2 STANDARD_DEVIATION 5.7 | 30.2 kg/m^2 STANDARD_DEVIATION 5.8 |
| Endoscopic Findings Normal esophagus | 7 Participants | 7 Participants | 14 Participants |
| Endoscopic Findings Reflux esophagitis | 2 Participants | 3 Participants | 5 Participants |
| Endoscopic Findings Varices | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 9 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ever Smoker | 3 Participants | 3 Participants | 6 Participants |
| Fat Intake | 35 % calories STANDARD_DEVIATION 5.6 | 33.5 % calories STANDARD_DEVIATION 2.6 | 34.3 % calories STANDARD_DEVIATION 4.3 |
| Fiber intake | 14.0 gm/day STANDARD_DEVIATION 3.8 | 13.6 gm/day STANDARD_DEVIATION 2.6 | 13.8 gm/day STANDARD_DEVIATION 3.2 |
| Gastroesophageal Reflux Disease (GERD) History | 7 Participants | 9 Participants | 16 Participants |
| Indication for Upper Endoscopy (EGD) Abdominal pain | 2 Participants | 2 Participants | 4 Participants |
| Indication for Upper Endoscopy (EGD) Dyspepsia | 1 Participants | 2 Participants | 3 Participants |
| Indication for Upper Endoscopy (EGD) Other | 2 Participants | 2 Participants | 4 Participants |
| Indication for Upper Endoscopy (EGD) Reflux symptoms | 5 Participants | 4 Participants | 9 Participants |
| Proton Pump Inhibitor (PPI) Use | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
| Waist to Hip Ratio (WHR) | 0.94 ratio STANDARD_DEVIATION 0.6 | 0.92 ratio STANDARD_DEVIATION 0.8 | 0.93 ratio STANDARD_DEVIATION 0.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: 21 days
Population: Data was not collected and analyzed for F. Nucleatum in particular, instead an analysis was done for the microbiome composition across sample sites - oral swab, saliva and esophageal.
Primary
Reduction of F. Nucleatum in Saliva
Within individual change in relative abundance of F nucleatum in oral samples
Time frame: 21 days
Population: Data was not collected and analyzed for F. Nucleatum in particular, instead an analysis was done for the microbiome composition across sample sites - oral swab, saliva and esophageal.