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A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of STIs in MSM Taking HIV PrEP (PReGo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881007
Recruitment Status : Terminated (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.)
First Posted : March 19, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

Brief Summary:
The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint) is able to reduce the cumulative incidence of gonorrhoea, chlamydia and syphilis in men who have sex with men and receiving preexposure prophylaxis at the Institute of Tropical Medicine.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Diseases Other: Mouthwash with LCM Other: Mouthwash with placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
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 : April 3, 2019
Actual Primary Completion Date : June 15, 2020
Actual Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LCM
Mouthwash with LCM
Other: Mouthwash with LCM
Subjects will mouthwash daily with LCM and before/after sex

Placebo Comparator: Placebo
Mouthwash with placebo
Other: Mouthwash with placebo
Subjects will mouthwash daily with placebo and before/after sex




Primary Outcome Measures :
  1. Incidence rate of NG plus Ct plus Syphilis in each study arm for each period [ Time Frame: 3-month period ]
    The sum of new diagnoses of Ng, 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 RPR and TPA tests according to currently used European case definitions


Secondary Outcome Measures :
  1. Difference in Incidence rate of pharyngeal Ng between each study arm for each period [ Time Frame: 3-month period ]
    Incidence rate of new pharyngeal Ng cases in each allocation arm for each study period of 3 months.

  2. Difference in Incidence rate of Ct (combined pharyngeal, urethral and rectal) between each study arm for each period [ Time Frame: 3-month period ]
    Incidence rate of new Ct cases in each allocation arm (LCM and placebo) for each study period of 3 months.

  3. Difference in Incidence rate of syphilis between periods on LCM vs. placebo [ Time Frame: 3-month period ]
    Incidence rate of new syphilis cases in each allocation arm (LCM and placebo) for each study period of 3 months.

  4. 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 ]

    Daily: Proportion of days in study used mouthwash at least daily Pre/post sex: Proportion of casual sexual contacts in study when mouthwash used pre and post sex.

    Pre sex: proportion of casual sexual contacts in study when mouthwash used pre sex


  5. 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 ]
    Incidence rate of Ng, Ct and syphilis between both groups (LCM and placebo) post controlling for adherence to mouthwash

  6. Difference in cumulative numbers of antibiotics used between periods on LCM vs. placebo [ Time Frame: 3-month period ]
    Cumulative number of antibiotics used between both groups (LCM and placebo) for each period

  7. Assess if resistance to LCM in Ng and N. flavescens can be induced (time to induction of LCM resistance) in the NGmorbidostat and if so which mutations are associated with resistance [ Time Frame: 6-month period ]
    Ng: Time to induction of LCM resistance N. flavescens: Time to induction of LCM resistance

  8. Assess if LCM-resistance-associated mutations are more prevalent (1) in those receiving LCM vs. placebo (Inter-individual comparison) (2) after 3 months on LCM than before receiving LCM (Intra-individual comparison) [ Time Frame: 3-month period ]
    Prevalence of LCM-resistance-associated mutations in the pharyngeal and rectal microbiome of the LCM group vs placebo-group. Prevalence of LCM-resistance-associated mutations in those receiving LCM after 3 months vs before receiving LCM.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881007


Locations
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Belgium
Institute of Tropical Medicine
Antwerp, Belgium, 2000
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Investigators
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Principal Investigator: Chris Kenyon, MD Institute of Tropical Medicine Antwerp
  Study Documents (Full-Text)

Documents provided by Institute of Tropical Medicine, Belgium:
Study Protocol  [PDF] January 8, 2020
Statistical Analysis Plan  [PDF] April 7, 2020

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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT03881007    
Other Study ID Numbers: ITM201801
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Data sharing for the PreGo trial will comply with ITMs Data Sharing Policy BEL-0171v1.1

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Available in clinicaltrials.gov

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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:
Gonorrhea
Syphilis
Chlamydia
Listerine
STI
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases