NCT02860845: DOBO

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

Completed Phase 4 Results posted Last updated 19 November 2019

What this trial tests

Phase 4 trial testing Boric acid and probiotics in Candidiasis in 48 participants. Completed in 30 November 2017.

Timeline

12 July 2016

Primary endpoint
16 October 2017

30 November 2017

Quick facts

Lead sponsor	Laboratorios Ordesa
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	12 July 2016
Primary completion	16 October 2017
Estimated completion	30 November 2017
Sites	1 location across Spain

Drugs / interventions tested

• Boric acid and probiotics
• Antibiotic (Clindamycin) — full drug profile →
• Antifungal (Clotrimazole) — full drug profile →

Conditions studied

• Candidiasis — all drugs for Candidiasis →
• Vaginosis, Bacterial — all drugs for Vaginosis, Bacterial →

Sponsor

Laboratorios Ordesa — full company profile →

Who can join

18 and older, female only, with Candidiasis or Vaginosis, Bacterial. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. Primary · Baseline and at 2 weeks after treatment finalization

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)

Stinging sobel score

Group	Value	95% CI
Boric Acid and Probiotics Baseline	1.13	± 0.85
Antibiotic/Antifungal Baseline	1.21	± 1.06
Boric Acid and Probiotics Visit 1	0.18	± 0.50
Antibiotic/Antifungal Visit 1	0.22	± 0.67

Itching Sobel Score

Group	Value	95% CI
Boric Acid and Probiotics Baseline	1.63	± 0.85
Antibiotic/Antifungal Baseline	1.58	± 1.02
Boric Acid and Probiotics Visit 1	0.41	± 0.80
Antibiotic/Antifungal Visit 1	0.57	± 0.95

Erythema Sobel Score

Group	Value	95% CI
Boric Acid and Probiotics Baseline	0.92	± 0.93
Antibiotic/Antifungal Baseline	0.96	± 1.12
Boric Acid and Probiotics Visit 1	0.14	± 0.64
Antibiotic/Antifungal Visit 1	0.17	± 0.65

Edema Sobel Score

Group	Value	95% CI
Boric Acid and Probiotics Baseline	0.5	± 0.78
Antibiotic/Antifungal Baseline	0.42	± 0.72
Boric Acid and Probiotics Visit 1	0.05	± 0.21
Antibiotic/Antifungal Visit 1	0	± 0.00

abnormal vaginal discharge

Group	Value	95% CI
Boric Acid and Probiotics Baseline	1.67	± 0.96
Antibiotic/Antifungal Baseline	1.96	± 1.08
Boric Acid and Probiotics Visit 1	0.23	± 0.53
Antibiotic/Antifungal Visit 1	0.35	± 0.83

Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. Secondary · Baseline and 2 weeks after treatment finalization

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

Group	Value	95% CI
Boric Acid and Probiotics Baseline	51.59	± 50.74
Antibiotic/Antifungal Baseline	49.30	± 59.77
Boric Acid and Probiotics Visit 1	81.82	± 84.34
Antibiotic/Antifungal Visit 1	66.09	± 77.27

Number of Participants With Recurrent Infections Secondary · At 3 months after recruitment

Descriptive of the proportion of patients with vulvovaginitis recurrence

No recurrence

Group	Value	95% CI
Boric Acid and Probiotics	17
Antibiotic/Antifungal	14

Recurrence

Group	Value	95% CI
Boric Acid and Probiotics	5
Antibiotic/Antifungal	9

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.