NCT02513784

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Esophageal Adenocarcinoma
• Barrett's Esophagus
• Reflux Esophagitis

Interventions

Type	Name	Description
DRUG	Chlorhexidine gluconate	Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-08-03
• Last updated: 2022-09-22
• Results posted: 2022-09-22

Locations

1 site across 1 country: United States