PReGo: A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP)
Sponsor
Institute of Tropical Medicine, Belgium (Other)
Overall Status
Terminated
CT.gov ID
NCT03881007
Collaborator
(none)
343
1
2
14.4
23.8
Study Details
Study Description
Brief Summary
The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint, LCM) is able to reduce the cumulative incidence of gonorrhoea (Ng), chlamydia (Ct) and syphilis in men who have sex with men and receiving preexposure prophylaxis (PrEP) at the Institute of Tropical Medicine (ITM).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study aims to assess if there is a difference in the incidence rate of gonorrhea, chlamydia and syphilis detected at any site whilst individuals are on daily and pre/post sex Listerine cool mint (LCM) vs. placebo mouthwash.
The study has a double-blind, cross-over design, in which subjects will be screened at the ITM and, if eligible, will be enrolled and randomized to group 1 (LCM) or group 2 (placebo). After 3 months, a crossover will occur and subjects will switch to the other intervention. Each participant will therefore be enrolled for 6 months (2 x 3 months, no wash out period).
Subjects will be recruited from the existing PrEP cohort at the Institute of Tropical Medicine Antwerp. A total of 320 subjects will be recruited (160 in each arm).
Study Design
Study Type:
Interventional
Actual Enrollment
:
343 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Double-blind Single Center, Crossover, Randomized Controlled Trial of Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Gonorrhea/Chlamydia/Syphilis in MSM Taking HIV Pre-exposure Prophylaxis (PrEP)
Actual Study Start Date
:
Apr 3, 2019
Actual Primary Completion Date
:
Jun 15, 2020
Actual Study Completion Date
:
Jun 15, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LCM, then placebo Mouthwash with LCM for 3 months followed by mouthwash with placebo for 3 months. |
Other: Mouthwash with LCM
Subjects will mouthwash daily with LCM and before/after sex
Other: Mouthwash with placebo
Subjects will mouthwash daily with placebo and before/after sex
|
| Experimental: Placebo, then LCM Mouthwash with placebo for 3 months followed by mouthwash with LCM for 3 months |
Other: Mouthwash with LCM
Subjects will mouthwash daily with LCM and before/after sex
Other: Mouthwash with placebo
Subjects will mouthwash daily with placebo and before/after sex
|
Outcome Measures
Primary Outcome Measures
- Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period [3-month period following each intervention]
The sum of new diagnoses of Gonnorhea (Ng), Chlamydia (Ct) and syphilis in a 3 month period on LCM/placebo. Each participant can only contribute one diagnosis of Ct and one diagnosis of Ng per visit - regardless of number of sites infected. Thus each participant can contribute up to 3 diagnoses (Ct/Ng/syphilis) at each visit. The diagnosis of Ng and Ct will be made via molecular testing and syphilis via Rapid Plasma Reagin test (RPR) and Treponema Pallidum Antibodies tests (TPA) according to currently used European case definitions.
Secondary Outcome Measures
- Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period [3-month period following each intervention]
Incidence rate of new pharyngeal Ng cases in each allocation arm for each study period of 3 months.
- Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period [3-month period following each intervention]
Incidence rate of new Ct cases in each allocation arm (LCM and placebo) for each study period of 3 months.
- Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo [3-month period following each intervention]
Incidence rate of new syphilis cases in each allocation arm (LCM and placebo) for each study period of 3 months.
- Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex [6-month period]
Daily: Proportion of days in study used mouthwash at least daily Post sex: Proportion of casual sexual contacts in study when mouthwash used post sex. Pre sex: proportion of casual sexual contacts in study when mouthwash used pre sex
- Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash [3-month period following each intervention]
Incidence rate of Ng, Ct and syphilis between both groups (LCM and placebo) post controlling for adherence to mouthwash
- Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo [3-month period following each intervention]
Cumulative number of antibiotics used between both groups (LCM and placebo) for each period
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Men aged 18 or more
-
Enrolled in Belgian PrEP program at ITM
-
Has had sex with another man in the previous year
-
Has had a symptomatic or asymptomatic STI (Ct/Ng/syphilis) in the previous 2 years
-
Willing to be enrolled in the cohort for 6 months and attend 3 monthly follow up visits
-
Willing to comply with the mouthwash study schema and willing to ask their casual partners to mouthwash pre- and post-sex
-
Prepared to fill out the online diary once a week
-
Able and willing to provide written informed consent
Exclusion Criteria:
-
Currently using a mouthwash and unwilling to cease use of this mouthwash
-
Enrolment in another interventional trial
-
Tests HIV positive at screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Tropical Medicine | Antwerp | Belgium | 2000 |
Sponsors and Collaborators
- Institute of Tropical Medicine, Belgium
Investigators
- Principal Investigator: Chris Kenyon, MD, Institute of Tropical Medicine Antwerp
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT03881007
Other Study ID Numbers:
- ITM201801
First Posted:
Mar 19, 2019
Last Update Posted:
May 7, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institute of Tropical Medicine, Belgium
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | LCM (Intervention), Then Placebo | Placebo, Then LCM (Intervention) |
|---|---|---|
| Arm/Group Description | Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex for 3 months and after 3 months they will switch to the placebo. | Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex during 3 months and after 3 months they will switch to the LCM mouthwash. |
| Period Title: First 3 Months | ||
| STARTED | 172 | 171 |
| COMPLETED | 121 | 119 |
| NOT COMPLETED | 51 | 52 |
| Period Title: First 3 Months | ||
| STARTED | 121 | 119 |
| COMPLETED | 77 | 74 |
| NOT COMPLETED | 44 | 45 |
Baseline Characteristics
| Arm/Group Title | LCM (Intervention), Then Placebo | Placebo, Then LCM | Total |
|---|---|---|---|
| Arm/Group Description | Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex for 3 months and then switch to placebo mouthwash for 3 months. | Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex for 3 months and then switch to LCM mouthwash for 3 months. | Total of all reporting groups |
| Overall Participants | 172 | 171 | 343 |
| Age (years) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [years] |
39
|
40
|
40
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
172
100%
|
171
100%
|
343
100%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Sexually Transmitted Infection (STI) history (last 24 months) (Count of Participants) | |||
| Any STI |
172
100%
|
171
100%
|
343
100%
|
| Chlamydia |
89
51.7%
|
82
48%
|
171
49.9%
|
| Gonorrhea |
100
58.1%
|
117
68.4%
|
217
63.3%
|
| Syphilis |
75
43.6%
|
66
38.6%
|
141
41.1%
|
| Other |
15
8.7%
|
21
12.3%
|
36
10.5%
|
| Antibiotics use (last 6 months) (Count of Participants) | |||
| Any antibiotics |
140
81.4%
|
136
79.5%
|
276
80.5%
|
| Macrolides |
71
41.3%
|
86
50.3%
|
157
45.8%
|
| Beta-lactam |
111
64.5%
|
121
70.8%
|
232
67.6%
|
| Fluoroquinolones |
4
2.3%
|
3
1.8%
|
7
2%
|
| Tetracyclines |
47
27.3%
|
30
17.5%
|
77
22.4%
|
| Other |
0
0%
|
2
1.2%
|
2
0.6%
|
| Number of main partners (last 3 months) (Main partners) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [Main partners] |
1
|
1
|
1
|
| Number of casual partners (last 3 months) (casual partners) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [casual partners] |
10
|
10
|
10
|
| Condom use with casual partners (Count of Participants) | |||
| 0-24% |
50
29.1%
|
62
36.3%
|
112
32.7%
|
| 25-49% |
42
24.4%
|
34
19.9%
|
76
22.2%
|
| 50-74% |
31
18%
|
26
15.2%
|
57
16.6%
|
| 75-100% |
44
25.6%
|
42
24.6%
|
86
25.1%
|
Outcome Measures
| Title | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period |
|---|---|
| Description | The sum of new diagnoses of Gonnorhea (Ng), Chlamydia (Ct) and syphilis in a 3 month period on LCM/placebo. Each participant can only contribute one diagnosis of Ct and one diagnosis of Ng per visit - regardless of number of sites infected. Thus each participant can contribute up to 3 diagnoses (Ct/Ng/syphilis) at each visit. The diagnosis of Ng and Ct will be made via molecular testing and syphilis via Rapid Plasma Reagin test (RPR) and Treponema Pallidum Antibodies tests (TPA) according to currently used European case definitions. |
| Time Frame | 3-month period following each intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months). |
| Arm/Group Title | LCM (Intervention) | Placebo |
|---|---|---|
| Arm/Group Description | Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex | Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex |
| Measure Participants | 195 | 196 |
| First 3 months : Any STI |
36
20.9%
|
33
19.3%
|
| First 3 months : Chlamydia |
19
11%
|
18
10.5%
|
| First 3 months : Gonorrhea |
19
11%
|
17
9.9%
|
| First 3 months : Syphilis |
2
1.2%
|
6
3.5%
|
| Last 3 months : Any STI |
27
15.7%
|
21
12.3%
|
| Last 3 months : Chlamydia |
11
6.4%
|
10
5.8%
|
| Last 3 months : Gonorrhea |
14
8.1%
|
8
4.7%
|
| Last 3 months : Syphilis |
4
2.3%
|
4
2.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LCM (Intervention), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.359 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Incidence rate ratio |
| Estimated Value | 1.17 | |
| Confidence Interval |
(2-Sided) 95% 0.84 to 1.64 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period |
|---|---|
| Description | Incidence rate of new pharyngeal Ng cases in each allocation arm for each study period of 3 months. |
| Time Frame | 3-month period following each intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months). |
| Arm/Group Title | LCM (Intervention) | Placebo |
|---|---|---|
| Arm/Group Description | Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex | Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex |
| Measure Participants | 195 | 196 |
| First 3 months |
8
|
2
|
| Last 3 months |
3
|
0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LCM (Intervention), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.024 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Incidence rate ratio |
| Estimated Value | 5.78 | |
| Confidence Interval |
(2-Sided) 95% 1.52 to 136.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period |
|---|---|
| Description | Incidence rate of new Ct cases in each allocation arm (LCM and placebo) for each study period of 3 months. |
| Time Frame | 3-month period following each intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months). |
| Arm/Group Title | LCM (Intervention) | Placebo |
|---|---|---|
| Arm/Group Description | Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex | Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex |
| Measure Participants | 195 | 196 |
| First 3 months |
19
|
18
|
| Last 3 months |
11
|
10
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LCM (Intervention), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.774 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Incidence rate ratio |
| Estimated Value | 1.09 | |
| Confidence Interval |
(2-Sided) 95% 0.61 to 1.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo |
|---|---|
| Description | Incidence rate of new syphilis cases in each allocation arm (LCM and placebo) for each study period of 3 months. |
| Time Frame | 3-month period following each intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months). |
| Arm/Group Title | LCM (Intervention) | Placebo |
|---|---|---|
| Arm/Group Description | Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex | Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex |
| Measure Participants | 195 | 196 |
| First 3 months |
2
|
6
|
| Last 3 months |
4
|
4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LCM (Intervention), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.323 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | incidence rate ratio |
| Estimated Value | 0.59 | |
| Confidence Interval |
(2-Sided) 95% 0.2 to 1.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex |
|---|---|
| Description | Daily: Proportion of days in study used mouthwash at least daily Post sex: Proportion of casual sexual contacts in study when mouthwash used post sex. Pre sex: proportion of casual sexual contacts in study when mouthwash used pre sex |
| Time Frame | 6-month period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population.LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months). |
| Arm/Group Title | LCM (Intervention) | Placebo |
|---|---|---|
| Arm/Group Description | Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex | Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex |
| Measure Participants | 195 | 196 |
| 0-24% |
11
6.4%
|
14
8.2%
|
| 25-49% |
8
4.7%
|
9
5.3%
|
| 50-74% |
17
9.9%
|
14
8.2%
|
| 75-100% |
80
46.5%
|
79
46.2%
|
| Missing |
5
2.9%
|
3
1.8%
|
| 0-24% |
6
3.5%
|
6
3.5%
|
| 25-49% |
4
2.3%
|
5
2.9%
|
| 50-74% |
9
5.2%
|
11
6.4%
|
| 75-100% |
15
8.7%
|
9
5.3%
|
| Missing |
40
23.3%
|
46
26.9%
|
| 0-24% |
30
17.4%
|
36
21.1%
|
| 25-49% |
15
8.7%
|
18
10.5%
|
| 50-74% |
20
11.6%
|
19
11.1%
|
| 75-100% |
49
28.5%
|
41
24%
|
| Missing |
7
4.1%
|
5
2.9%
|
| 0-24% |
19
11%
|
13
7.6%
|
| 25-49% |
13
7.6%
|
15
8.8%
|
| 50-74% |
13
7.6%
|
18
10.5%
|
| 75-100% |
25
14.5%
|
24
14%
|
| Missing |
4
2.3%
|
7
4.1%
|
| 0-24% |
31
18%
|
38
22.2%
|
| 25-49% |
16
9.3%
|
16
9.4%
|
| 50-74% |
22
12.8%
|
26
15.2%
|
| 75-100% |
45
26.2%
|
34
19.9%
|
| Missing |
7
4.1%
|
5
2.9%
|
| 0-24% |
22
12.8%
|
14
8.2%
|
| 25-49% |
13
7.6%
|
17
9.9%
|
| 50-74% |
14
8.1%
|
18
10.5%
|
| 75-100% |
21
12.2%
|
21
12.3%
|
| Missing |
4
2.3%
|
7
4.1%
|
| Title | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash |
|---|---|
| Description | Incidence rate of Ng, Ct and syphilis between both groups (LCM and placebo) post controlling for adherence to mouthwash |
| Time Frame | 3-month period following each intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months). |
| Arm/Group Title | LCM (Intervention) | Placebo |
|---|---|---|
| Arm/Group Description | Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex | Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex |
| Measure Participants | 195 | 196 |
| First 3 months: Any STIs |
36
20.9%
|
33
19.3%
|
| First 3 months: Chlamydia |
19
11%
|
18
10.5%
|
| First 3 months: Gonorrhea |
19
11%
|
17
9.9%
|
| First 3 months: Syphilis |
2
1.2%
|
6
3.5%
|
| Last 3 months: Any STI |
27
15.7%
|
21
12.3%
|
| Last 3 months: Chlamydia |
11
6.4%
|
10
5.8%
|
| Last 3 months: Gonorrhea |
14
8.1%
|
8
4.7%
|
| Last 3 months: Syphilis |
4
2.3%
|
4
2.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LCM (Intervention), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.279 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Incidence rate ratio |
| Estimated Value | 1.21 | |
| Confidence Interval |
(2-Sided) 95% 0.86 to 1.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo |
|---|---|
| Description | Cumulative number of antibiotics used between both groups (LCM and placebo) for each period |
| Time Frame | 3-month period following each intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| The overall number of participants analyzed is for both study periods. The number analyzed per row is the number of participants analyzed per period. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months). |
| Arm/Group Title | LCM (Intervention) | Placebo |
|---|---|---|
| Arm/Group Description | Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex | Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex |
| Measure Participants | 195 | 196 |
| Month 3 |
49
28.5%
|
55
32.2%
|
| Month 6 |
39
22.7%
|
35
20.5%
|
Adverse Events
| Time Frame | Adverse events and serious adverse events were collected over the whole study duration (6 months) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months). | |||
| Arm/Group Title | LCM (Intervention) | Placebo | ||
| Arm/Group Description | Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex. The total of participants at risk for the LCM intervention is 195 (121 in first 3 months and 77 in last 3 months). | Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex. The total of participants at risk for the LCM intervention is 196 (119 in first 3 months and 74 in last 3 months). | ||
All Cause Mortality |
||||
| LCM (Intervention) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/195 (0%) | 0/196 (0%) | ||
Serious Adverse Events |
||||
| LCM (Intervention) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/195 (0.5%) | 3/196 (1.5%) | ||
| Infections and infestations | ||||
| Ludwig Angina | 1/195 (0.5%) | 1 | 0/196 (0%) | 0 |
| HIV | 0/195 (0%) | 0 | 1/196 (0.5%) | 1 |
| Psychiatric disorders | ||||
| Suicidal depression | 0/195 (0%) | 0 | 1/196 (0.5%) | 1 |
| Reproductive system and breast disorders | ||||
| Testis carcinoma | 0/195 (0%) | 0 | 1/196 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| LCM (Intervention) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 45/195 (23.1%) | 30/196 (15.3%) | ||
| Gastrointestinal disorders | ||||
| Dental caries | 19/195 (9.7%) | 19 | 12/196 (6.1%) | 12 |
| Tooth discoloration | 26/195 (13.3%) | 26 | 18/196 (9.2%) | 18 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Chris Kenyon |
|---|---|
| Organization | Institute of Tropical Medicine Antwerp |
| Phone | +32(0)32470786 |
| ckenyon@itg.be |
Responsible Party:
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT03881007
Other Study ID Numbers:
- ITM201801
First Posted:
Mar 19, 2019
Last Update Posted:
May 7, 2021
Last Verified:
Apr 1, 2021