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This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibacterial mouthwash | Experimental | Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days. |
|
| No intervention | No Intervention | Subjects will be randomized to no intervention for 21 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate | Drug | Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of F. Nucleatum in Saliva | Within individual change in relative abundance of F nucleatum in oral samples | 21 days |
| 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. | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian A. Abrams, MD, MS | Assistant Professor of Medicine and Epidemiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33512805 | Derived | 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. |
| Label | URL |
|---|---|
| Clinical and Translational Gastroenterology: December 2020 - Volume 11 - Issue 12 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | No Intervention | Subjects will be randomized to no intervention for 21 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | No Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction of F. Nucleatum in Saliva | Within individual change in relative abundance of F nucleatum in oral samples | 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. | Posted | 21 days |
|
21 days
Participants were instructed to report any side effects of chlorhexidine. Tooth discoloration (a possible side effect of chlorhexidine use) was assessed by a dentist using photographs. The dentist was blinded to whether the images were from pre- or post-treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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There were no indications for repeated endoscopies, so the analysis of the esophagus was limited to a single point in time; relatively small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julian A Abrams, MD | Columbia University Medical Center | 2123059541 | ja660@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2021 | Jun 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
| D001471 | Barrett Esophagus |
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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Subjects will be randomized to no intervention for 21 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Proton Pump Inhibitor (PPI) Use | Count of Participants | Participants |
|
| Aspirin Use | Count of Participants | Participants |
|
| Ever Smoker | Count of Participants | Participants |
|
| Gastroesophageal Reflux Disease (GERD) History | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Waist to Hip Ratio (WHR) | Waist to Hip Ratio | Mean | Standard Deviation | ratio |
|
| Fat Intake | Mean | Standard Deviation | % calories |
|
| Fiber intake | Mean | Standard Deviation | gm/day |
|
| Indication for Upper Endoscopy (EGD) | Count of Participants | Participants |
|
| Endoscopic Findings | Count of Participants | Participants |
|
|
| 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. | 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. | Posted | 21 days |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | No Intervention | Subjects will be randomized to no intervention for 21 days. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D004066 |
| Digestive System Diseases |
| D004941 | Esophagitis |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |