NCT02513784

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

September 22, 2022

Completed
Last Updated

September 22, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

July 30, 2015

Results QC Date

June 11, 2021

Last Update Submit

August 27, 2022

Conditions

Esophageal AdenocarcinomaBarrett's EsophagusReflux Esophagitis

Keywords

MicrobiomeEsophagusEndoscopyMouthwash

Outcome Measures

Primary Outcomes (2)

  • Reduction of F. Nucleatum in Saliva

    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

    Comparison of relative abundance of esophageal F. nucleatum in the mouthwash group vs. the no intervention group.

    21 days

Study Arms (2)

Antibacterial mouthwash

EXPERIMENTAL

Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.

Drug: Chlorhexidine gluconate

No intervention

NO INTERVENTION

Subjects will be randomized to no intervention for 21 days.

Interventions

Chlorhexidine gluconateDRUG

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

Also known as: Peridex
Antibacterial mouthwash

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • Scheduled for upper endoscopy for clinical indications
  • No allergy or other contraindication to chlorhexidine

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Annavajhala 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: 33512805DERIVED

Related Links

MeSH Terms

Conditions

Adenocarcinoma Of EsophagusBarrett EsophagusEsophagitis, Peptic

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesEsophagitisGastroenteritisPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach Diseases

Limitations and Caveats

There were no indications for repeated endoscopies, so the analysis of the esophagus was limited to a single point in time; relatively small sample size.

Results Point of Contact

Title
Julian A Abrams, MD
Organization
Columbia University Medical Center
ja660@cumc.columbia.edu
2123059541

Study Officials

  • Julian A. Abrams, MD, MS

    Assistant Professor of Medicine and Epidemiology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 3, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 22, 2022

Results First Posted

September 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)