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

Candidiasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860845
• Other study ID #: DOBO-01-16
• Status: Completed
• Phase: Phase 4
• Start date: July 12, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: November 2019
• Source: Laboratorios Ordesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 30, 2017
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Device:
• Boric acid and probiotics
Vaginal capsules administered once a day during 7 days.

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Ginemed Sevilla	Sevilla	Andalucía

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Ordesa	Clever Instruments S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Participants With Recurrent Infections	Descriptive of the proportion of patients with vulvovaginitis recurrence	At 3 months after recruitment