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Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections (DOBO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02860845
Recruitment Status : Completed
First Posted : August 9, 2016
Results First Posted : November 4, 2019
Last Update Posted : November 19, 2019
Clever Instruments S.L.
Information provided by (Responsible Party):
Laboratorios Ordesa

Brief Summary:
The 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).

Condition or disease Intervention/treatment Phase
Candidiasis Vaginosis, Bacterial Device: Boric acid and probiotics Drug: Antibiotic (Clindamycin) Drug: Antifungal (Clotrimazole) Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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.

  2. Number of Participants With Recurrent Infections [ Time Frame: At 3 months after recruitment ]
    Descriptive of the proportion of patients with vulvovaginitis recurrence

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02860845

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Ginemed Sevilla
Sevilla, Andalucía, Spain
Sponsors and Collaborators
Laboratorios Ordesa
Clever Instruments S.L.
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Principal Investigator: Juan A Tena, Dr. Ginemed Sevilla
  Study Documents (Full-Text)

Documents provided by Laboratorios Ordesa:
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Responsible Party: Laboratorios Ordesa Identifier: NCT02860845    
Other Study ID Numbers: DOBO-01-16
First Posted: August 9, 2016    Key Record Dates
Results First Posted: November 4, 2019
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Anti-Bacterial Agents
Clindamycin palmitate
Clindamycin phosphate
Antifungal Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors