Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis
Phase 2
- Conditions
- Bacterial Vaginosis Treatment
- Interventions
- Drug: Vaginal Probiotic
- Registration Number
- NCT03234517
- Lead Sponsor
- Zagazig University
- Brief Summary
Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis
- Detailed Description
Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results of treatment at different time intervals was done.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria
- more than 18 years
- has recurrent Bacterial Vaginosis
Exclusion Criteria
- pregnancy
- use of other antmicrobial
- not provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic Vaginal Clindamycin Cream Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic Vaginal Clindamycin Cream Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic Vaginal Probiotic Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic Vaginal Probiotic Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use
- Primary Outcome Measures
Name Time Method initial cure rate 2 months number of women completely cured
- Secondary Outcome Measures
Name Time Method recurrence rate 4,6,8and12 months number of women had recurrence
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie clindamycin and probiotic synergy in restoring vaginal lactobacillus dominance for bacterial vaginosis?
How does continuous vs interrupted probiotic administration with clindamycin compare to standard metronidazole/tinidazole therapy in BV recurrence rates?
Which microbial biomarkers predict successful Lactobacillus recolonization after clindamycin-probiotic combination therapy in Phase 2 trials?
What are the safety profiles of clindamycin cream plus probiotics regarding local adverse events like irritation or discharge in BV patients?
How do clindamycin-based combination therapies compare to other antibiotic-probiotic regimens (e.g., metronidazole + Lactobacillus) in treating anaerobic BV subtypes?
Trial Locations
- Locations (1)
Zagazig University
🇪🇬Zagazig, Egypt