Health Condition 1: B373- Candidiasis of vulva and vagina
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| evaluate the recurrence rate in the study population for 6 monthsTimepoint: 6 months after initiating therapy | — |
Countries
India
Contacts
ALL INDIA INSTITUTE OF MEDICAL SCIENCES