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

Barrett's Esophagus Clinical Trial

— Mouthwash  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513784
• Other study ID #: AAAP4553
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Esophageal Adenocarcinoma
• Esophagitis
• Esophagitis, Peptic
• Reflux Esophagitis

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of F. Nucleatum in Saliva	Within individual change in relative abundance of F nucleatum in oral samples	21 days
Primary	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.	21 days

External Links

•   Clinical and Translational Gastroenterology: December 2020 - Volume 11 - Issue 12