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

Sponsor
Laboratorios Ordesa (Industry)
Overall Status
Completed
CT.gov ID
NCT02860845
Collaborator
Clever Instruments S.L. (Industry)
48
Enrollment
1
Location
2
Arms
16.6
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Jul 12, 2016
Actual Primary Completion Date :
Oct 16, 2017
Actual Study Completion Date :
Nov 30, 2017

Arms and Interventions

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 Names:
  • Clindamycin

    • Drug: Antifungal (Clotrimazole)
    Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
    Other Names:
  • Clotrimazole

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. [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. [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 [At 3 months after recruitment]

      Descriptive of the proportion of patients with vulvovaginitis recurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ginemed Sevilla Sevilla Andalucía Spain

    Sponsors and Collaborators

    • Laboratorios Ordesa
    • Clever Instruments S.L.

    Investigators

    • Principal Investigator: Juan A Tena, Dr., Ginemed Sevilla

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Laboratorios Ordesa
    ClinicalTrials.gov Identifier:
    NCT02860845
    Other Study ID Numbers:
    • DOBO-01-16
    First Posted:
    Aug 9, 2016
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Candidiasis
    Vaginosis, Bacterial
    Vaginal Diseases
    Anti-Bacterial Agents
    Clindamycin
    Clindamycin palmitate
    Clindamycin phosphate
    Clotrimazole
    Miconazole
    Antifungal Agents

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Boric Acid and Probiotics Antibiotic/Antifungal
    Arm/Group Description Boric acid with L.gasseri and L.rhamnosus Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
    Period Title: Overall Study
    STARTED 24 24
    Analyzed Patients 22 23
    COMPLETED 22 23
    NOT COMPLETED 2 1

    Baseline Characteristics

    Arm/Group Title Boric Acid and Probiotics Antibiotic/Antifungal Total
    Arm/Group Description Boric acid with L.gasseri and L.rhamnosus Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days. Total of all reporting groups
    Overall Participants 24 24 48
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    24
    100%
    24
    100%
    48
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    36.36
    (8.2)
    37.7
    (6.1)
    36.83
    (7.22)
    Sex: Female, Male (Count of Participants)
    Female
    24
    100%
    24
    100%
    48
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    White, non latino
    23
    95.8%
    24
    100%
    47
    97.9%
    Latino
    1
    4.2%
    0
    0%
    1
    2.1%
    Region of Enrollment (participants) [Number]
    Spain
    24
    100%
    24
    100%
    48
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.
    Description 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)
    Time Frame Baseline and at 2 weeks after treatment finalization

    Outcome Measure Data

    Analysis Population Description
    Subscore Sobel Score values at baseline and visit 1 (from 0 to 3)
    Arm/Group Title Boric Acid and Probiotics Baseline Antibiotic/Antifungal Baseline Boric Acid and Probiotics Visit 1 Antibiotic/Antifungal Visit 1
    Arm/Group Description Boric acid with L.gasseri and L.rhamnosus Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): 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 Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
    Measure Participants 24 24 22 23
    Stinging sobel score
    1.13
    (0.85)
    1.21
    (1.06)
    0.18
    (0.50)
    0.22
    (0.67)
    Itching Sobel Score
    1.63
    (0.85)
    1.58
    (1.02)
    0.41
    (0.80)
    0.57
    (0.95)
    Erythema Sobel Score
    0.92
    (0.93)
    0.96
    (1.12)
    0.14
    (0.64)
    0.17
    (0.65)
    Edema Sobel Score
    0.5
    (0.78)
    0.42
    (0.72)
    0.05
    (0.21)
    0
    (0.00)
    abnormal vaginal discharge
    1.67
    (0.96)
    1.96
    (1.08)
    0.23
    (0.53)
    0.35
    (0.83)
    2. Secondary Outcome
    Title Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.
    Description Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures.
    Time Frame Baseline and 2 weeks after treatment finalization

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Boric Acid and Probiotics Baseline Antibiotic/Antifungal Baseline Boric Acid and Probiotics Visit 1 Antibiotic/Antifungal Visit 1
    Arm/Group Description Boric acid with L.gasseri and L.rhamnosus Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): 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 Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
    Measure Participants 24 24 22 23
    Mean (Standard Deviation) [Count of Organism/counting chamber]
    51.59
    (50.74)
    49.30
    (59.77)
    81.82
    (84.34)
    66.09
    (77.27)
    3. Secondary Outcome
    Title Number of Participants With Recurrent Infections
    Description Descriptive of the proportion of patients with vulvovaginitis recurrence
    Time Frame At 3 months after recruitment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Boric Acid and Probiotics Antibiotic/Antifungal
    Arm/Group Description Boric acid with L.gasseri and L.rhamnosus Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
    Measure Participants 22 23
    No recurrence
    17
    70.8%
    14
    58.3%
    Recurrence
    5
    20.8%
    9
    37.5%

    Adverse Events

    Time Frame From baseline to three months
    Adverse Event Reporting Description
    Arm/Group Title Boric Acid and Probiotics Antibiotic/Antifungal
    Arm/Group Description Boric acid with L.gasseri and L.rhamnosus Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
    All Cause Mortality
    Boric Acid and Probiotics Antibiotic/Antifungal
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/24 (0%) 0/24 (0%)
    Serious Adverse Events
    Boric Acid and Probiotics Antibiotic/Antifungal
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/24 (0%) 0/24 (0%)
    Other (Not Including Serious) Adverse Events
    Boric Acid and Probiotics Antibiotic/Antifungal
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/24 (0%) 0/24 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Roser De Castellar
    Organization Laboratorios Ordesa
    Phone +34 902105243
    Email Roser.DeCastellar@ordesa.es
    Responsible Party:
    Laboratorios Ordesa
    ClinicalTrials.gov Identifier:
    NCT02860845
    Other Study ID Numbers:
    • DOBO-01-16
    First Posted:
    Aug 9, 2016
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Nov 1, 2019