Clinical trial · Interventional
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
NCT02513784CI-TRIAL-00060978MouthwashcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Reflux Esophagitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorhexidine gluconate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Antibacterial mouthwash
- description
- Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.
- interventionNames
- Drug: Chlorhexidine gluconate
- type
- NO_INTERVENTION
- label
- No intervention
- description
- Subjects will be randomized to no intervention for 21 days.
Primary outcomes (2)
- measure
- Reduction of F. Nucleatum in Saliva
- timeFrame
- 21 days
- description
- Within individual change in relative abundance of F nucleatum in oral samples
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAnnavajhala MK, May M, Compres G, Freedberg DE, Graham R, Stump S, Que J, Korem T, Uhlemann AC, Abrams JA. Relationship of the Esophageal Microbiome and Tissue Gene Expression and Links to the Oral Microbiome: A Randomized Clinical Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00235. doi: 10.14309/ctg.0000000000000235. PMID 33512805