An interventional study of Chlorhexidine gluconate in Esophageal Adenocarcinoma, Barrett's Esophagus and Reflux Esophagitis, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-22.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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.
126 studies on the registry are indexed under Adenocarcinoma Of Esophagus; 72 are open to participants now.
This study's enrollment of 20 is below the median of 74 across 110 interventional studies indexed under Adenocarcinoma Of Esophagus.
Browse Adenocarcinoma Of Esophagus studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.
Drug: Chlorhexidine gluconate
Subjects will be randomized to no intervention for 21 days.
Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.
Also known as: Peridex
Reduction of F. Nucleatum in Saliva
Within individual change in relative abundance of F nucleatum in oral samples
Time frame: 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.
Time frame: 21 days
| Milestone | Antibacterial Mouthwash | No Intervention |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Within individual change in relative abundance of F nucleatum in oral samples
No measurements were reported for this outcome.
Comparison of relative abundance of esophageal F. nucleatum in the mouthwash group vs. the no intervention group.
No measurements were reported for this outcome.
Collected over 21 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antibacterial Mouthwash | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| No Intervention | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Antibacterial Mouthwash | No Intervention | Total |
|---|---|---|---|
| Mean | 53.5 ± 12.9 | 51.2 ± 15.5 | 52.4 ± 13.9 |
| Sex: Female, Male(Participants) | Antibacterial Mouthwash | No Intervention | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 4 | 4 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Antibacterial Mouthwash | No Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 9 | 17 |
| Not Hispanic or Latino | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Antibacterial Mouthwash | No Intervention | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
| Proton Pump Inhibitor (PPI) Use(Participants) | Antibacterial Mouthwash | No Intervention | Total |
|---|---|---|---|
| Count of participants | 5 | 5 | 10 |
| Aspirin Use(Participants) | Antibacterial Mouthwash | No Intervention | Total |
|---|---|---|---|
| Count of participants | 4 | 4 | 8 |
| Ever Smoker(Participants) | Antibacterial Mouthwash | No Intervention | Total |
|---|---|---|---|
| Count of participants | 3 | 3 | 6 |
| Gastroesophageal Reflux Disease (GERD) History(Participants) | Antibacterial Mouthwash | No Intervention | Total |
|---|---|---|---|
| Count of participants | 7 | 9 | 16 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
The record gives a start of Aug 2015, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2022, 4 years 9 months after primary completion. A results delay was requested in Jul 2019.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chlorhexidine gluconate