Comparison of microbial and biochemical properties of vaginal discharge in patients with and without bacterial infection of vagina.
Not Applicable
- Conditions
- Health Condition 1: N898- Other specified noninflammatory disorders of vagina
- Registration Number
- CTRI/2018/12/016499
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients who are BV positive using the Gold standard for BV diagnosis- Nugentâ??s score
2. BV positive women in the reproductive age group (18-45 years)
3. Presence of abnormal vaginal discharge
Exclusion Criteria
1. Presence of co-existing STIs contributing to discharge
2. Patients who are HIV positive
3. Iatrogenic or systemic illness
4. Presence of associated co-morbidities (diabetes, auto immune conditions, chronic illness
requiring regular drug intake).
5. Patients receiving oral drugs within the last 3months (antibiotics / regular use of oral drugs)
6. Patients receiving topical treatment within the last 2 weeks (intra-vaginal)
7. Douching/ use of vaginal hygiene products in the last 3 days.
8. Use of oral contraceptives
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to identify the microbiota and metabolite profiles of the vaginal discharge in patients with BV and compare them that of healthy controls.Timepoint: 0, 1 week, 1 months, 3 months, 6 months, 9 months and 12 months and at the time of relapse if any.
- Secondary Outcome Measures
Name Time Method To assess the potential of metagenomics and metabolims as diagnostic tool for BVTimepoint: 3 years