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

NCT ID: NCT02860845

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-12
• Study Completion Date: 2017-11-30

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.

Conditions

Candidiasis; Vaginosis, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Boric acid and probiotics

Boric acid with L.gasseri and L.rhamnosus

Group Type: EXPERIMENTAL

Boric acid and probiotics

Intervention Type: DEVICE

Vaginal capsules administered once a day during 7 days.

Antibiotic/Antifungal

Antibiotic: Clindamicine Antifungal: Clotrimazol

Group Type: ACTIVE_COMPARATOR

Antibiotic (Clindamycin)

Intervention Type: DRUG

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

Antifungal (Clotrimazole)

Intervention Type: DRUG

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

Interventions

Boric acid and probiotics

Vaginal capsules administered once a day during 7 days.

Intervention Type: DEVICE

Antibiotic (Clindamycin)

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

Intervention Type: DRUG

Antifungal (Clotrimazole)

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

Intervention Type: DRUG

Other Intervention Names

Clindamycin; Clotrimazole

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clever Instruments S.L.

INDUSTRY

Sponsor Role: collaborator

Laboratorios Ordesa

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan A Tena, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ginemed Sevilla

Locations

Ginemed Sevilla

Seville, Andalusia, Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DOBO-01-16

Identifier Type: -

Identifier Source: org_study_id