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

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

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).

Study Overview

• Status: Completed
• Conditions: Candidiasis; Vaginosis, Bacterial
• Intervention / Treatment: Device: Boric acid and probiotics; Drug: Antibiotic (Clindamycin); Drug: Antifungal (Clotrimazole)

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Andalucía
    • Sevilla, Andalucía, Spain
      • Ginemed Sevilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 2 weeks after treatment finalization
Number of Participants With Recurrent Infections	Descriptive of the proportion of patients with vulvovaginitis recurrence	At 3 months after recruitment

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Collaborators: Clever Instruments S.L.
• Investigators: Principal Investigator: Juan A Tena, Dr., Ginemed Sevilla

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2016
• Primary Completion (Actual): October 16, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Mycoses; Vaginitis; Candidiasis; Vaginal Diseases; Vaginosis, Bacterial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Anti-Bacterial Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Antifungal Agents; Clotrimazole; Miconazole
• Other Study ID Numbers: DOBO-01-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No