CompletedNot Applicable

Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome

United States20 participantsStarted 2015-08

Plain-language summary

This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction of F. Nucleatum in Saliva

Timeframe: 21 days

Difference in Esophageal F. Nucleatum Between Experimental Group and no Intervention Group

Timeframe: 21 days

Trial details

NCT IDNCT02513784

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

Results submitted2021-06-11

View on ClinicalTrials.gov More Esophageal Adenocarcinoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.