Phase IIb clinical trial on selected strains of probiotic lactobacilli packed as Capsules/Tablets for colonization potential and efficacy against recurrence of Bacterial Vaginosis
- Conditions
- Health Condition 1: null- Recurring episodes of Bacterial Vaginosis in women
- Registration Number
- CTRI/2010/091/000236
- Lead Sponsor
- Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
1.Women between age groups of 18-45 with regular cycles
2.Clinical history of chronic and/ or recurring episodes of abnormal vaginal dischargre. On pelvic examination,they are seen to have either excessive or unhealthy vaginal discharge.
3.Willing to participate in the study after having been explained about the nature of the body. Willing to return for follow up after 5-7 days of completion of treatment and thereafter on monthly basis for 3 months in part I of study.
1.Known case of diabetes mellitus.
2. Suspected/confirmed pregnancy.
3.Suspected or known malignancy of reproductive tract
4.Less than 6 weeks since last delivery or abortion
5.H/O severe allergic reaction
6. Abnormalities of vaginal anatomy which will interfere with placement of drug
7. Known systemic diseases, immuno-compromised states
8. Adnexal mass or tenderness
9. Received a course of antibiotic therapy, less than 14 days prior to enrollment
10. Dysfunction uterine bleeding
11.Vaginal polyp
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method