Trial Outcomes & Findings for Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome (NCT NCT02513784)
NCT ID: NCT02513784
Last Updated: 2022-09-22
Results Overview
Within individual change in relative abundance of F nucleatum in oral samples
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
21 days
Results posted on
2022-09-22
Participant Flow
Participant milestones
| Measure |
Antibacterial Mouthwash
Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.
Chlorhexidine gluconate: Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.
|
No Intervention
Subjects will be randomized to no intervention for 21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome
Baseline characteristics by cohort
| Measure |
Antibacterial Mouthwash
n=10 Participants
Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.
Chlorhexidine gluconate: Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.
|
No Intervention
n=10 Participants
Subjects will be randomized to no intervention for 21 days.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Proton Pump Inhibitor (PPI) Use
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Aspirin Use
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ever Smoker
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Gastroesophageal Reflux Disease (GERD) History
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Body Mass Index
|
29.2 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Waist to Hip Ratio (WHR)
|
0.94 ratio
STANDARD_DEVIATION 0.6 • n=5 Participants
|
0.92 ratio
STANDARD_DEVIATION 0.8 • n=7 Participants
|
0.93 ratio
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Fat Intake
|
35 % calories
STANDARD_DEVIATION 5.6 • n=5 Participants
|
33.5 % calories
STANDARD_DEVIATION 2.6 • n=7 Participants
|
34.3 % calories
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Fiber intake
|
14.0 gm/day
STANDARD_DEVIATION 3.8 • n=5 Participants
|
13.6 gm/day
STANDARD_DEVIATION 2.6 • n=7 Participants
|
13.8 gm/day
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Indication for Upper Endoscopy (EGD)
Reflux symptoms
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Indication for Upper Endoscopy (EGD)
Abdominal pain
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Indication for Upper Endoscopy (EGD)
Dyspepsia
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Indication for Upper Endoscopy (EGD)
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Endoscopic Findings
Reflux esophagitis
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Endoscopic Findings
Varices
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Endoscopic Findings
Normal esophagus
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Data was not collected and analyzed for F. Nucleatum in particular, instead an analysis was done for the microbiome composition across sample sites - oral swab, saliva and esophageal.
Within individual change in relative abundance of F nucleatum in oral samples
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 21 daysPopulation: Data was not collected and analyzed for F. Nucleatum in particular, instead an analysis was done for the microbiome composition across sample sites - oral swab, saliva and esophageal.
Comparison of relative abundance of esophageal F. nucleatum in the mouthwash group vs. the no intervention group.
Outcome measures
Outcome data not reported
Adverse Events
Antibacterial Mouthwash
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place