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OpenTrials
Completed

NCT Number: NCT02513784

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gluconate

Drug

Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.

Other names: Peridex

Primary outcomes

  1. Reduction of F. Nucleatum in Saliva

    Time frame: 21 days

    Within individual change in relative abundance of F nucleatum in oral samples

  2. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Pilot Randomized Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal and Gastric Microbiome

Acronym: Mouthwash

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2015
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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