Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections (DOBO)
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|ClinicalTrials.gov Identifier: NCT02860845|
Recruitment Status : Completed
First Posted : August 9, 2016
Results First Posted : November 4, 2019
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Candidiasis Vaginosis, Bacterial||Device: Boric acid and probiotics Drug: Antibiotic (Clindamycin) Drug: Antifungal (Clotrimazole)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 12, 2016|
|Actual Primary Completion Date :||October 16, 2017|
|Actual Study Completion Date :||November 30, 2017|
Experimental: Boric acid and probiotics
Boric acid with L.gasseri and L.rhamnosus
Device: Boric acid and probiotics
Vaginal capsules administered once a day during 7 days.
Active Comparator: Antibiotic/Antifungal
Antibiotic: Clindamicine Antifungal: Clotrimazol
Drug: Antibiotic (Clindamycin)
Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.
Other Name: Clindamycin
Drug: Antifungal (Clotrimazole)
Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
Other Name: Clotrimazole
- Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. [ Time Frame: Baseline and at 2 weeks after treatment finalization ]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)
- Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. [ Time Frame: Baseline and 2 weeks after treatment finalization ]Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures.
- Number of Participants With Recurrent Infections [ Time Frame: At 3 months after recruitment ]Descriptive of the proportion of patients with vulvovaginitis recurrence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860845
|Sevilla, Andalucía, Spain|
|Principal Investigator:||Juan A Tena, Dr.||Ginemed Sevilla|