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

August 27, 2022 updated by: Columbia University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antibacterial mouthwash
Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.
Drug: Chlorhexidine gluconate
Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.
Other Names:
  • Peridex
No Intervention: No intervention
Subjects will be randomized to no intervention for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of F. Nucleatum in Saliva
Time Frame: 21 days
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
Time Frame: 21 days
Comparison of relative abundance of esophageal F. nucleatum in the mouthwash group vs. the no intervention group.
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Julian A. Abrams, MD, MS, Assistant Professor of Medicine and Epidemiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 3, 2015

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

August 27, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAP4553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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