Prevention of recurrence of Bacterial Vaginosis using lactobacilli containing vaginal tablets among HIV infected wome
- Conditions
- Health Condition 1: null- HIV infected women with confirmed bacterial vaginosis
- Registration Number
- CTRI/2018/04/013298
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 80
Positive HIV serology obtained prior to enrollment HIV infected women
Age 18 years to 40 years
Having regular menstrual cycles
Willing to be abstinent for the period when she is using vaginal tablets (either lactobacilli containing or placebo) i.e 15 days in the first month and 8 days every month for next three months
Having Facility to store study vaginal tablets at desired temperature (between 2-8 degree) for 8 days every month for first four months
Able and willing to provide written informed consent
Bacterial vaginosis positive as defined by amselâ??s criteria and confirmed by Nugentâ??s score
Oral or Vaginal antimicrobial or probiotics therapy within 14 days prior to enrollment
Pregnancy or lactating upto 6 months
Reported or known allergy /sensitivity to Tab Metronidazole or lactobacilli containing formulations
Use of any vaginal medication in the previous 7 days of enrollment
Any condition that in the opinion of the study staff would make participation in the study unsafe complicate interpretation of study outcome data or otherwise interfere with achieving the study objective
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A diagnosis of Bacterial Vaginosis confirmed with Nugents score in participants in either study arm after completion of four cycles of study vaginal tablets i.e. after 5th month visitTimepoint: every month after 5th month up to 12 months
- Secondary Outcome Measures
Name Time Method AcceptibilityTimepoint: At five month visit;Adherance to productTimepoint: For Tablet Metronidazole <br/ ><br>1)8th day visit <br/ ><br>2)21-30 day visit <br/ ><br>For Lactobacillus tablet and placebo:at 3,4,5 month visit respectively;Comparison of cervical HIV shedding in HIV infected women with Bacterial Vaginosis before and after treatment with study vaginal tabletsTimepoint: 1)Baseline <br/ ><br>2)21-30 day (visit after first cycle of study vaginal tablets) <br/ ><br>3)At three month visit-after completion of 4 cycle of study vaginal tablets;Comparison of inflammatory markers of innate immunity in cervical samplesTimepoint: 1)Baseline <br/ ><br>2)21-30 day visit (after first cycle of study vaginal tablets) <br/ ><br>3)At five month visit (after completion of 4 cycle of study vaginal tablets)