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 : Unknown
Verified August 2016 by Laboratorios Ordesa.
Recruitment status was: Recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
|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)|
|Estimated Enrollment :||50 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|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||April 2017|
|Experimental: Boric acid and probiotics||
Device: Boric acid and probiotics
Vaginal capsules administered once a day during 7 days.
|Active Comparator: Antibiotic/Antifungal||
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 ]
- Change in the level of lactobacillus in vaginal flora determined by vaginal cultures. [ Time Frame: Baseline and 2 weeks after treatment finalization ]
- Number of recurrent infections rate determined by medical evaluation of clinical symptoms. [ Time Frame: At 3 months after recruitment ]
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|
|Contact: Juan A Tena, Dr.|
|Principal Investigator:||Juan A Tena, Dr.||Ginemed Sevilla|