Rwanda Vaginal Microbiota Restoration Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-05

Study Completion Date

2018-08-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV)

NCT03769688

Bacterial Vaginosis

WITHDRAWN PHASE1

Vaginal lIve Biotherapeutic RANdomized Trial

NCT06135974

Bacterial Vaginosis

COMPLETED EARLY_PHASE1

Multi-Center Study of New Medications to Treat Vaginal Infections

NCT02308033

Vaginal Infection

COMPLETED PHASE3

Study of the Vaginal Microbiota and the Potential of a Vaginal Probiotic Cream in Vaginal Candidosis

NCT03975569

Candidiasis, Vulvovaginal

COMPLETED NA

Multi-Center Study of New Medications to Treat Vaginal Infections

NCT02308046

Vaginal Infection

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a pilot study to prepare for larger clinical trials. Sixty-eight HIV-negative, non-pregnant, sexually active women aged 18-45 with bacterial vaginosis (BV, by modified Amsel criteria and/or Nugent score) and/or Trichomonas vaginalis (TV, on wet mount or by culture) will be treated using oral metronidazole for 7 days. After successful treatment, and when they are free of vaginal candidiasis, other curable sexually transmitted infections (STIs) and urinary tract infection (UTI)), they will be randomised to 4 different vaginal microbiome (VMB) maintenance interventions (17 per group) within 3 days of completing oral metronidazole treatment: 1) Behavioral 'vaginal practices cessation and safer sex' counselling only (control); 2) Behavioral counselling plus 500mg metronidazole pills twice per week for two months; 3) Behavioral counselling plus Ecologic Femi vaginal capsule, once per day for 5 days immediately after oral metronidazole treatment followed by thrice weekly, for two months; 4) Group 4: Behavioral counselling plus Gynophilus vaginal tablet, once every 4 days for two months. Vaginal probiotic use may be ceased temporarily during menstruation. Participants will be asked to adhere to the interventions for 2 months, and VMB assessments will take place before (screening and enrolment visits), during (Day 7, Month 1 and Month 2 visits), and after the interventions (Month 6 visit).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Vaginosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Negative control group: After initial treatment for BV/TV, no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

Positive control group: After initial treatment for BV/TV, metronidazole pills (500 mg) twice per week for 2 months.

Group Type OTHER

Prophylactic use of metronidazole pills (500 mg)

Intervention Type DRUG

Prophylactic use of metronidazole pills to prevent BV recurrence after metronidazole treatment for BV or TV

Group 3

After initial treatment for BV/TV, Ecologic Femi+ vaginal capsule (a vaginal probiotic) once per day for 5 days immediately after the initial treatment followed by thrice weekly for two months.

Group Type ACTIVE_COMPARATOR

Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence

Intervention Type BIOLOGICAL

Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV

Group 4

After initial treatment for BV/TV, Gynophilus LP vaginal tablet (a vaginal probiotic) once every 4 days for two months.

Group Type ACTIVE_COMPARATOR

Vaginal Lcr35-containing probiotic for prevention of BV recurrence

Intervention Type BIOLOGICAL

Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence

Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV

Intervention Type BIOLOGICAL

Prophylactic use of metronidazole pills (500 mg)

Prophylactic use of metronidazole pills to prevent BV recurrence after metronidazole treatment for BV or TV

Intervention Type DRUG

Vaginal Lcr35-containing probiotic for prevention of BV recurrence

Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ecologic Femi+ vaginal capsule Tricozole Gynophilus LP vaginal tablet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No