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)

NCT03881007 | Terminated Results

• 1 other identifier: ITM201801
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

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).

Conditions

Sexually Transmitted Diseases

Keywords

Gonorrhea; Syphilis; Chlamydia; Listerine; STI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period

  3-month period following each intervention

• Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period

  3-month period following each intervention

• Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo

  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

  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

  3-month period following each intervention

Study Arms (2)

LCM, then placebo

EXPERIMENTAL

Mouthwash with LCM for 3 months followed by mouthwash with placebo for 3 months.

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

Other: Mouthwash with LCM; Other: Mouthwash with placebo

Interventions

Mouthwash with LCM OTHER

Subjects will mouthwash daily with LCM and before/after sex

LCM, then placebo; Placebo, then LCM

Mouthwash with placebo OTHER

Subjects will mouthwash daily with placebo and before/after sex

LCM, then placebo; Placebo, then LCM

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Institute of Tropical Medicine

Antwerp, 2000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 36557750 DERIVED

• 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.

  PMID: 33676596 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Gonorrhea; Syphilis; Chlamydia Infections

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Treponemal Infections; Spirochaetales Infections; Chlamydiaceae Infections

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Chris Kenyon
• Organization: Institute of Tropical Medicine Antwerp

ckenyon@itg.be

+32(0)32470786

Study Officials

• Chris Kenyon, MD

  Institute of Tropical Medicine Antwerp

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: April 3, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: May 7, 2021
• Results First Posted: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available in clinicaltrials.gov

Locations

BE (1)