Title
Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections
Multicenter Pilot Study to Compare the Efficacy of a Combination of Vaginal Capsules With Acid Boric, L.Gasseri and L.Rhamnosus Versus the Reference Medication in Patients With Vaginal Candidiasis or Bacterial Vaginosis
Phase
Phase 4Lead Sponsor
Laboratorios OrdesaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Candidiasis Vaginosis, BacterialIntervention/Treatment
urea boric acid autologous microbiome clindamycin ...Study Participants
48The purpose of this study is to determine whether a formula of boric acid and probiotics for vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis in comparison to pharmacological reference controls (depending on the suspected diagnosis).
Multicentre, Open, Prospective, Randomized, Controlled. Women with suspected vaginal infection will be randomized and distributed into two groups (control or boric acid + probiotics). Follow-up will last for three months and consists in 3 visits and a telephone interview.
Vaginal capsules administered once a day during 7 days.
Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.
Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
Boric acid with L.gasseri and L.rhamnosus
Antibiotic: Clindamicine Antifungal: Clotrimazol
Inclusion Criteria: Age over 18 years and agreement to participate by signing the consent form. Women with clinical manifestations of acute infectious vulvovaginitis (burning, pruritus, erythema, oedema, and abnormal vaginal discharge). Exclusion Criteria: Clinical findings compatible with Chlamydia trachomatis, Neisseria gonorrhoeae or Trichomonas vaginalis infection. Use of anti-fungal, antibiotic or probiotic medication within last 2 weeks prior to the study. Patients receiving other treatment (drug, probiotics or vitamin supplements) that can significantly interfere with study evaluations during the 3 months of follow-up. Pregnant or high risk for pregnancy.
| Event Type | Organ System | Event Term |
|---|
Semi-quantitative scale where itching, erythema, edema, stinging and abnormal vaginal discharge are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3). Worse result is 3 (severe)
Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures.
Descriptive of the proportion of patients with vulvovaginitis recurrence
