Sexually Transmitted DiseasesPReGoNCT03881007

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)

A study testing Mouthwash with LCM in people with Sexually Transmitted Diseases, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Sexually Transmitted Diseases
What is being tested?: Mouthwash with LCM
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 343 participants
Where: 1 siteBelgium
Study dates: 3 Apr 2019to 15 Jun 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Currently using a mouthwash and unwilling to cease use of this mouthwash
Enrolment in another interventional trial
Tests HIV positive at screening

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Institute of Tropical Medicine
Antwerp, 2000

Other trials in Belgium

About this study

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)

Read the 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).

Conditions: Sexually Transmitted Diseases
Being tested: Mouthwash with LCM, Mouthwash with placebo
Keywords: Gonorrhea, Syphilis, Chlamydia, Listerine, STI
Medical subject headings: Sexually Transmitted Diseases, Gonorrhea, Syphilis, Chlamydia Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mouthwash with LCMOther
Subjects will mouthwash daily with LCM and before/after sex
Mouthwash with placeboOther
Subjects will mouthwash daily with placebo and before/after sex

Study groups in NCT03881007
Study group	Role	What they receive
LCM, then placebo	Experimental	Mouthwash with LCM for 3 months followed by mouthwash with placebo for 3 months. Receives: Other: Mouthwash with LCM; Other: Mouthwash with placebo
Placebo, then LCM	Experimental	Mouthwash with placebo for 3 months followed by mouthwash with LCM for 3 months Receives: Other: Mouthwash with LCM; Other: Mouthwash with placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3-month period following each intervention

Secondary outcomes (6)

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.
Measured: 3-month period following each intervention
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 3-month period following each intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 201915 Jun 2020

First posted19 Mar 2019
Study start3 Apr 2019
Primary completion15 Jun 2020
Study completion15 Jun 2020

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 343 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03881007
Sponsor's protocol ID: ITM201801
Acronym: PReGo
Status last verified: Apr 2021
First submitted: 13 Mar 2019
Last updated: 7 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 36557750
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.
PubMed 33676596

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03881007
Acronym / sponsor ID: PReGo / ITM201801
Conditions: Sexually Transmitted Diseases
Keywords: Gonorrhea, Syphilis, Chlamydia, Listerine, STI
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 343 participants (actual)
Lead sponsor: Institute of Tropical Medicine, BelgiumUniversity, hospital or other
Study start: 3 Apr 2019 (actual)
Primary completion: 15 Jun 2020 (actual)
Study completion: 15 Jun 2020 (actual)
First posted: 19 Mar 2019 (actual)
Results: Posted 6 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LCM, then placebo	Experimental	Other: Mouthwash with LCM, Other: Mouthwash with placeboMouthwash with LCM for 3 months followed by mouthwash with placebo for 3 months.
Placebo, then LCM	Experimental	Other: Mouthwash with LCM, Other: Mouthwash with placeboMouthwash with placebo for 3 months followed by mouthwash with LCM for 3 months

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (3 listed)

Currently using a mouthwash and unwilling to cease use of this mouthwash
Enrolment in another interventional trial
Tests HIV positive at screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mouthwash with LCMSubjects will mouthwash daily with LCM and before/after sex	Other	LCM, then placebo, Placebo, then LCM
Mouthwash with placeboSubjects will mouthwash daily with placebo and before/after sex	Other	LCM, then placebo, Placebo, then LCM

Primary outcome

Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period
Time frame: 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.

6 secondary outcomes

Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period
Time frame: 3-month period following each intervention
Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period
Time frame: 3-month period following each intervention
Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo
Time frame: 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
Time frame: 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
Time frame: 3-month period following each intervention
Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo
Time frame: 3-month period following each intervention

Results and safety

Results posted to the registry on 6 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LCM (Intervention), Then Placebo	172	121
Placebo, Then LCM (Intervention)	171	119

Primary outcome: Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period

Time frame: 3-month period following each intervention. Count of participants. Unit: Participants

Measure	LCM (Intervention) n = 195	Placebo n = 196
First 3 months : Any STI	36	33
First 3 months : Chlamydia	19	18
First 3 months : Gonorrhea	19	17
First 3 months : Syphilis	2	6
Last 3 months : Any STI	27	21
Last 3 months : Chlamydia	11	10
Last 3 months : Gonorrhea	14	8
Last 3 months : Syphilis	4	4

LCM (Intervention) vs Placebo: Incidence rate ratio: 1.17 (95% CI 0.84 to 1.64), p = 0.359, Mixed Models Analysis

Population analysed: 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).

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and serious adverse events were collected over the whole study duration (6 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LCM (Intervention)	1 of 195 (0.5%)	45 of 195 (23.1%)	0 of 195
Placebo	3 of 196 (1.5%)	30 of 196 (15.3%)	0 of 196

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36557750Akomoneh 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.
Derived from this study: PubMed 33676596Van 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chris Kenyon, MD principal investigator

Institute of Tropical Medicine Antwerp

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mouthwash with LCM in people with Sexually Transmitted Diseases, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period (time frame: 3-month period following each intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03881007, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.