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An interim analysis, planned because of the influence of the COVID-lockdown, showed the LCM mouthwash did not affect the incidence of Ng, Ct and syphilis.
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCM, then placebo | Experimental | Mouthwash with LCM for 3 months followed by mouthwash with placebo for 3 months. |
|
| Placebo, then LCM | Experimental | Mouthwash with placebo for 3 months followed by mouthwash with LCM for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mouthwash with LCM | Other | Subjects will mouthwash daily with LCM and before/after sex |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | 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. | 3-month period following each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period | Incidence rate of new pharyngeal Ng cases in each allocation arm for each study period of 3 months. | 3-month period following each intervention |
| Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Kenyon, MD | Institute of Tropical Medicine Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Tropical Medicine | Antwerp | 2000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36557750 | Derived | Akomoneh EA, Laumen JGE, Abdellati S, Van Dijck C, Vanbaelen T, Britto XB, Manoharan-Basil SS, Kenyon C. The Discovery of Oropharyngeal Microbiota with Inhibitory Activity against Pathogenic Neisseria gonorrhoeae and Neisseria meningitidis: An In Vitro Study of Clinical Isolates. Microorganisms. 2022 Dec 16;10(12):2497. doi: 10.3390/microorganisms10122497. | |
| 33676596 |
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Data sharing for the PreGo trial will comply with ITMs Data Sharing Policy.
Study data might be made available for secondary research and analyses to external researchers by means of a managed access procedure within 12 months of publication date. Because of privacy concerns, access requests will be reviewed and approved prior to release by ITMs Data Access Committee. Requests for access can be made centrally through:
https://www.itg.be/E/data-sharing-open-access The possibility of sharing (anonymized) study data is also mentioned in the Informed Consent Form and approved by the Ethics Committees that approved the initial PreGo clinical trial protocol.
Available in clinicaltrials.gov
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| ID | Title | Description |
|---|---|---|
| FG000 | LCM (Intervention), Then Placebo | 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. |
| FG001 | Placebo, Then LCM (Intervention) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First 3 Months |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2020 | Jul 15, 2020 |
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| Mouthwash with placebo | Other | Subjects will mouthwash daily with placebo and before/after sex |
|
Incidence rate of new Ct cases in each allocation arm (LCM and placebo) for each study period of 3 months. |
| 3-month period following each intervention |
| Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo | Incidence rate of new syphilis cases in each allocation arm (LCM and placebo) for each study period of 3 months. | 3-month period following each intervention |
| 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 | 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 | 6-month period |
| 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 | Incidence rate of Ng, Ct and syphilis between both groups (LCM and placebo) post controlling for adherence to mouthwash | 3-month period following each intervention |
| Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo | Cumulative number of antibiotics used between both groups (LCM and placebo) for each period | 3-month period following each intervention |
| Van Dijck C, Tsoumanis A, Rotsaert A, Vuylsteke B, Van den Bossche D, Paeleman E, De Baetselier I, Brosius I, Laumen J, Buyze J, Wouters K, Lynen L, Van Esbroeck M, Herssens N, Abdellati S, Declercq S, Reyniers T, Van Herrewege Y, Florence E, Kenyon C. Antibacterial mouthwash to prevent sexually transmitted infections in men who have sex with men taking HIV pre-exposure prophylaxis (PReGo): a randomised, placebo-controlled, crossover trial. Lancet Infect Dis. 2021 May;21(5):657-667. doi: 10.1016/S1473-3099(20)30778-7. Epub 2021 Mar 4. |
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. |
| COMPLETED |
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| NOT COMPLETED |
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| Last 3 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LCM (Intervention), Then Placebo | 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. |
| BG001 | Placebo, Then LCM | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Sexually Transmitted Infection (STI) history (last 24 months) | Count of Participants | Participants |
| ||||||||||||||||
| Antibiotics use (last 6 months) | Count of Participants | Participants |
| ||||||||||||||||
| Number of main partners (last 3 months) | Median | Inter-Quartile Range | Main partners |
| |||||||||||||||
| Number of casual partners (last 3 months) | Median | Inter-Quartile Range | casual partners |
| |||||||||||||||
| Condom use with casual partners | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | 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. | 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). | Posted | Count of Participants | Participants | 3-month period following each intervention |
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| Secondary | Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period | Incidence rate of new pharyngeal Ng cases in each allocation arm for each study period of 3 months. | 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). | Posted | Number | diagnoses | 3-month period following each intervention |
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| Secondary | Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period | Incidence rate of new Ct cases in each allocation arm (LCM and placebo) for each study period of 3 months. | 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). | Posted | Number | diagnoses | 3-month period following each intervention |
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| Secondary | Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo | Incidence rate of new syphilis cases in each allocation arm (LCM and placebo) for each study period of 3 months. | 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). | Posted | Number | diagnoses | 3-month period following each intervention |
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| Secondary | 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 | 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 | 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). | Posted | Count of Participants | Participants | 6-month period |
|
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| Secondary | 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 | Incidence rate of Ng, Ct and syphilis between both groups (LCM and placebo) post controlling for adherence to mouthwash | 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). | Posted | Count of Participants | Participants | 3-month period following each intervention |
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| Secondary | Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo | Cumulative number of antibiotics used between both groups (LCM and placebo) for each period | 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). | Posted | Count of Participants | Participants | 3-month period following each intervention |
|
|
Adverse events and serious adverse events were collected over the whole study duration (6 months)
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCM (Intervention) | 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). | 0 | 195 | 1 | 195 | 45 | 195 |
| EG001 | Placebo | 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). | 0 | 196 | 3 | 196 | 30 | 196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ludwig Angina | Infections and infestations | Systematic Assessment |
| ||
| Suicidal depression | Psychiatric disorders | Systematic Assessment |
| ||
| Testis carcinoma | Reproductive system and breast disorders | Systematic Assessment |
| ||
| HIV | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tooth discoloration | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chris Kenyon | Institute of Tropical Medicine Antwerp | +32(0)32470786 | ckenyon@itg.be |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2020 | Jul 15, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D006069 | Gonorrhea |
| D013587 | Syphilis |
| D002690 | Chlamydia Infections |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D002694 | Chlamydiaceae Infections |
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| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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|
|
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| Chlamydia |
|
|
| Gonorrhea |
|
|
| Syphilis |
|
|
| Other |
|
|
|
| Macrolides |
|
|
| Beta-lactam |
|
|
| Fluoroquinolones |
|
|
| Tetracyclines |
|
|
| Other |
|
|
|
|
|
| 25-49% |
|
|
| 50-74% |
|
|
| 75-100% |
|
|
| First 3 months : Chlamydia |
|
|
| First 3 months : Gonorrhea |
|
|
| First 3 months : Syphilis |
|
|
| Last 3 months : Any STI |
|
|
| Last 3 months : Chlamydia |
|
|
| Last 3 months : Gonorrhea |
|
|
| Last 3 months : Syphilis |
|
|
|
|
|
|
|
|
|
|
|
|
| 25-49% |
|
| 50-74% |
|
| 75-100% |
|
| Missing |
|
| 25-49% |
|
| 50-74% |
|
| 75-100% |
|
| Missing |
|
| 25-49% |
|
| 50-74% |
|
| 75-100% |
|
| Missing |
|
| 25-49% |
|
| 50-74% |
|
| 75-100% |
|
| Missing |
|
| 25-49% |
|
| 50-74% |
|
| 75-100% |
|
| Missing |
|