To use biochemical properties of vaginal discharge for possible diagnosis of bacterial vaginosis and predict treatment outcome.
Not Applicable
- Conditions
- Health Condition 1: N898- Other specified noninflammatory disorders of vagina
- Registration Number
- CTRI/2018/12/016508
- 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 Amsel criteria
2. BV positive women in the reproductive age group (18-45 years)
3. Presence of abnormal vaginal discharge
Exclusion Criteria
Presence of co-existing STIs contributing to discharge
2. Patients who are HIV positive
3. Iatrogenic or systemic illness or metabolic disorders.
4. Presence of associated co-morbidities
5. Patients who have received oral drugs within the last 4 weeks
6. Patients who have received topical or intravaginal treatment within the last 4 weeks
7. Pregnant and lactating women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To analyze the microbiota compositiion and metabolic profiles of women with bacterial vaginosis and compare them with health controls.Timepoint: 0, 4 weeks, 1 year/relapse whichever earlier
- Secondary Outcome Measures
Name Time Method To explore diagnostic and/or predictive potential of metabolomics by comparing with existing diagnostic modalities.Timepoint: 2 years