Rwanda Vaginal Microbiota Restoration Study

• Status: Completed
• Trial end date: 2018-08-06
• Target enrollment: 0
• Participant gender: Female

Summary

A pilot randomized controlled clinical trial of intermittent use of two different vaginal lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis recurrence.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janneke van de Wijgert
• Collaborator: Rinda Ubuzima, Rwanda
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

• Sexually active, defined as having had sex at least twice in the two weeks prior to screening

• At high risk of HIV/STIs/BV, defined as having had more than one sexual partner in the last 12 months OR having been treated for an STI and/or BV in the last 12 months

• Successfully treated for BV (modified Amsel criteria) or TV (wet mount), and free of STIs, symptomatic vaginal candidiasis and UTI at enrollment

• Currently in good physical and mental health as judged by a study physician

• Willing and able to adhere to study procedures and provide written informed consent.

Exclusion Criteria:

• Pregnant

• HIV positive

• Clinician-observed genital ulcers, condylomata, or other genital abnormalities at screening or enrollment

• Underwent a gynaecological surgery/invasive procedure in the 3 months prior to screening

• History of significant urogenital prolapse, undiagnosed vaginal bleeding, urine or faecal incontinence, or blood clotting disorders

• Allergic to metronidazole or any other components of the study drugs

• Not willing to stop use of other oral or vaginal probiotics from the screening visit until the end of study participation

• Participating in another health intervention study

• For any other reason potentially interfering with participant safety or protocol adherence as judged by the Principal Investigator