NCT03881007

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 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)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-03
• Primary completion: 2020-06-15
• Completion: 2020-06-15
• First posted: 2019-03-19
• Last updated: 2021-05-07
• Results posted: 2021-04-06

Locations

1 site across 1 country: Belgium