Rwanda Vaginal Microbiota Restoration Study (VMB)

Janneke van de Wijgert

Status: Completed

Conditions: Bacterial Vaginosis

Treatments: Biological: Vaginal Lcr35-containing probiotic for prevention of BV recurrence; Biological: Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence; Drug: Prophylactic use of metronidazole pills (500 mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT02459665

RETH000828

Details and patient eligibility

About

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

Full description

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).

Enrollment: 68 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 4 patient groups

Group 1

No Intervention group

Description:

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

Group 2

Other group

Description:

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

Treatment:

Drug: Prophylactic use of metronidazole pills (500 mg)

Group 3

Active Comparator group

Description:

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.

Treatment:

Biological: Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence

Group 4

Active Comparator group

Description:

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

Treatment:

Biological: Vaginal Lcr35-containing probiotic for prevention of BV recurrence