Esophageal AdenocarcinomaMouthwashNCT02513784
Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome
A study testing Chlorhexidine gluconate in people with Esophageal Adenocarcinoma and Barrett's Esophagus, run by Columbia University at 1 site in United States.
Trial summary
This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Adenocarcinoma, Barrett's Esophagus, Reflux Esophagitis
- What is being tested?
- Chlorhexidine gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18
- Scheduled for upper endoscopy for clinical indications
- No allergy or other contraindication to chlorhexidine
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Pilot Randomized Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal and Gastric Microbiome
This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome
Read the 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.
- Being tested
- Chlorhexidine gluconate
- Keywords
- Microbiome, Esophagus, Endoscopy, Mouthwash
- Medical subject headings
- Adenocarcinoma Of Esophagus, Barrett Esophagus, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Also called Peridex
Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.
| Study group | Role | What they receive |
|---|---|---|
| Antibacterial mouthwash | Experimental | Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days. Receives: Drug: Chlorhexidine gluconate |
| No intervention | No intervention | Subjects will be randomized to no intervention for 21 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of F. Nucleatum in Saliva
Within individual change in relative abundance of F nucleatum in oral samples
Measured: 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.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian A. Abrams, MD, MS, Principal investigator, Assistant Professor of Medicine and Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513784
- Sponsor's protocol ID
- AAAP4553
- Acronym
- Mouthwash
- Status last verified
- Aug 2022
- First submitted
- 30 Jul 2015
- Last updated
- 22 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33512805
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal and Gastric Microbiome
- ClinicalTrials.gov ID
- NCT02513784
- Acronym / sponsor ID
- Mouthwash / AAAP4553
- Keywords
- Microbiome, Esophagus, Endoscopy, Mouthwash
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Posted 22 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibacterial mouthwash | Experimental | Drug: Chlorhexidine gluconateSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18
- Scheduled for upper endoscopy for clinical indications
- No allergy or other contraindication to chlorhexidine
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine gluconateAlso: PeridexChlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth. | Drug | Antibacterial mouthwash |
Primary outcome
Reduction of F. Nucleatum in Saliva
Time frame: 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
Time frame: 21 days
Comparison of relative abundance of esophageal F. nucleatum in the mouthwash group vs. the no intervention group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33512805Annavajhala 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.
- Clinical and Translational Gastroenterology: December 2020 - Volume 11 - Issue 12Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian A. Abrams, MD, MS principal investigator
Assistant Professor of Medicine and Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine gluconate in people with Esophageal Adenocarcinoma and Barrett's Esophagus, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of F. Nucleatum in Saliva (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02513784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.