Role of Oral Probiotics in Vaginal Candidiasis
Phase 4
- Conditions
- Health Condition 1: B373- Candidiasis of vulva and vagina
- Registration Number
- CTRI/2024/07/070646
- Lead Sponsor
- All India Institute of Medical Sciences Bibinagar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion Criteria: Adult premenopausal women (age 18-50 years), Symptomatic vulvovaginal candidiasis
Exclusion Criteria
Vaginal infections different from VVC, Women treated with other probiotics, pregnancy, lactation, menstruation and a subject’s unwillingness to provide informed consent to participate in the trial. History of systemic organic diseases or psychiatric diseases; Other pathologies (immunodeficiency, diabetes, oestrogen-dependent tumours). Long-term use of contraceptives or immunosuppressants; Use of douching, Anaphylactic constitution or allergic to known ingredients of research drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to evaluate the efficacy of a multispecies oral probiotic formulation Lactobacillus mixture in combination with bifidobacterium bifidum (capsule combinorm, Abbott Pharma India) given orally as an adjuvant to oral standard antimicrobial therapy in women with symptomatic vulvovaginal candidiasisTimepoint: at 2 months after initiating the therapy, if symptoms persists every 2 months until 6 months
- Secondary Outcome Measures
Name Time Method evaluate the recurrence rate in the study population for 6 monthsTimepoint: 6 months after initiating therapy