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

Primary Purpose

Candidiasis, Vaginosis, Bacterial

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Boric acid and probiotics

Antibiotic (Clindamycin)

Antifungal (Clotrimazole)

About this trial

This is an interventional treatment trial for Candidiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Ginemed Sevilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Boric acid and probiotics

Antibiotic/Antifungal

Arm Description

Boric acid with L.gasseri and L.rhamnosus

Antibiotic: Clindamicine Antifungal: Clotrimazol

Outcomes

Primary Outcome Measures

Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.

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

Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.

Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures.

Number of Participants With Recurrent Infections

Descriptive of the proportion of patients with vulvovaginitis recurrence

Full Information

NCT ID

NCT02860845

First Posted

July 19, 2016

Last Updated

November 5, 2019

Sponsor

Laboratorios Ordesa

Collaborators

Clever Instruments S.L.

1. Study Identification

Unique Protocol Identification Number

NCT02860845

Brief Title

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

Acronym

DOBO

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 Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

July 12, 2016 (Actual)

Primary Completion Date

October 16, 2017 (Actual)

Study Completion Date

November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Ordesa

Collaborators

Clever Instruments S.L.

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Candidiasis, Vaginosis, Bacterial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Boric acid and probiotics

Arm Type

Experimental

Arm Description

Boric acid with L.gasseri and L.rhamnosus

Arm Title

Antibiotic/Antifungal

Arm Type

Active Comparator

Arm Description

Antibiotic: Clindamicine Antifungal: Clotrimazol

Intervention Type

Device

Intervention Name(s)

Boric acid and probiotics

Intervention Description

Vaginal capsules administered once a day during 7 days.

Intervention Type

Drug

Intervention Name(s)

Antibiotic (Clindamycin)

Other Intervention Name(s)

Clindamycin

Intervention Description

Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.

Intervention Type

Drug

Intervention Name(s)

Antifungal (Clotrimazole)

Other Intervention Name(s)

Clotrimazole

Intervention Description

Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

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

Title

Number of Participants With Recurrent Infections

Description

Descriptive of the proportion of patients with vulvovaginitis recurrence

Time Frame

At 3 months after recruitment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan A Tena, Dr.

Organizational Affiliation

Ginemed Sevilla

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ginemed Sevilla

City

Sevilla

State/Province

Andalucía

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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