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

NCT02860845 | Completed Phase 4 Results DMC

• 1 other identifier: DOBO-01-16
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Candidiasis; Vaginosis, Bacterial

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline and at 2 weeks after treatment finalization

Secondary Outcomes (2)

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

  Baseline and 2 weeks after treatment finalization

• Number of Participants With Recurrent Infections

  At 3 months after recruitment

Study Arms (2)

Boric acid and probiotics

EXPERIMENTAL

Boric acid with L.gasseri and L.rhamnosus

Device: Boric acid and probiotics

Antibiotic/Antifungal

ACTIVE COMPARATOR

Antibiotic: Clindamicine Antifungal: Clotrimazol

Drug: Antibiotic (Clindamycin); Drug: Antifungal (Clotrimazole)

Interventions

Boric acid and probiotics DEVICE

Vaginal capsules administered once a day during 7 days.

Boric acid and probiotics

Antibiotic (Clindamycin) DRUG

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

Also known as: Clindamycin

Antibiotic/Antifungal

Antifungal (Clotrimazole) DRUG

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

Also known as: Clotrimazole

Antibiotic/Antifungal

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Ordesa: lead
• Clever Instruments S.L.: collaborator

Study Sites (1)

Ginemed Sevilla

Seville, Andalusia, Spain

Location

MeSH Terms

Conditions

Candidiasis; Vaginosis, Bacterial

Interventions

Anti-Bacterial Agents; Clindamycin; Antifungal Agents; Clotrimazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Bacterial Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Imidazoles; Azoles

Results Point of Contact

• Title: Roser De Castellar
• Organization: Laboratorios Ordesa

Roser.DeCastellar@ordesa.es

+34 902105243

Study Officials

• Juan A Tena, Dr.

  Ginemed Sevilla

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: August 9, 2016
• Study Start: July 12, 2016
• Primary Completion: October 16, 2017
• Study Completion: November 30, 2017
• Last Updated: November 19, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)