N/A
N=68
Rwanda Vaginal Microbiota Restoration Study
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT02459665 ↗Enrolled (actual)
68
Serious AEs
2.9%
Results posted
Jul 2019
Primary outcome: Primary: Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria — 7.53; 2.04; 3.36; 3.35 Incidence: events per PY at risk
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence (Biological); Prophylactic use of metronidazole pills (500 mg) (Drug); Vaginal Lcr35-containing probiotic for prevention of BV recurrence (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Janneke van de Wijgert
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria |
7.53; 2.04; 3.36; 3.35 | — |
| PRIMARY Bacterial Vaginosis (BV) Incidence by Nugent Scoring (Nugent 7-10) |
10.18; 1.41; 3.58; 5.36 | — |
| PRIMARY Trichomonas Vaginalis (TV) Incidence by Culture |
1.10; 0; 0; 0 | — |
| PRIMARY Vaginal Candidiasis Incidence by Wet Mount Microscopy |
0; 0; 0; 0 | — |
| SECONDARY Vaginal Microbiota Composition by Illumina HiSeq Sequencing: Lactobacillus Genus Concentration |
3.86; 5.21; 5.30; 4.68 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02459665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.