Efficacy of oral Probiotic therapy for women with Vulvovaginal Candidiasis: A randomized controlled study

A prospective randomized single-centre clinical trial. Consenting, eligible women will be randomly allocated to use standard antibiotic therapy plus probiotics (group 1) or only standard antibiotic therapy (group 2). Randomization is created by a computer 1:1 scheme.

Treatment will consist of 2 different phases:

During the induction phase, all eligible enrolled women with clinical symptoms and signs of VVC such as vulvar burning, vulvar itching, and abnormal vaginal discharge as well as the patients with positive fungal cultures will be included in this study. They will be treated with standard antifungal therapy (Tab Fluconazole 150mg oral stat) and will be randomly assigned to one of two study arms receiving (group 1) for oral probiotic (2 capsules/day for 5 days followed by further 10 consecutive days at the dosage of 1 capsule/day) in the induction phase. Group 2 will receive tab fluconazole 150 mg stat only. During the maintenance phase (a month following the induction phase), group 1 will be given 1 capsule of probiotic per day for 10 consecutive days per month in the premenstrual phase (prophylactic treatment). This timeline is related to the consideration that the recurrence, typically, occurs in the premenstrual or luteal phase, in VVC.All participating women will attend 4 visits (from T0 to T3) at the gynaecological OPD. At recruitment (T0), after the succeeding menstrual cycle (T1), 2 months from T1(T2), and the final visit (T3) at 6 months after the initial visit. In each clinical examination, 2 vaginal swabs are collected. During the first visit (baseline), the patient’s medical history will be recorded, informed consent will be signed, and women will be allocated into the two study arms. Visits from T0 to T3 are to check the efficacy and safety of the investigational product. The symptoms will be evaluated (vaginal discharge, itching) which are self-reported by the patients as present or absent during gynecologic visits.  A sample of vaginal secretion will be analyzed for vaginal pH using special pH strips (range 3.8-5.0). Baseline diagnosis of vulvovaginal candidiasis and trichomoniasis are made by routinely used diagnostic procedures