Phase 4
Completed N=48
Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections
Candidiasis · Vaginosis, Bacterial
Source: ClinicalTrials.gov NCT02860845 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. — 1.13; 1.21; 0.18; 0.22 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. |
1.13; 1.21; 0.18; 0.22; 1.63; 1.58 | — |
| SECONDARY Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. |
51.59; 49.30; 81.82; 66.09 | — |
| SECONDARY Number of Participants With Recurrent Infections |
17; 14; 5; 9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02860845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.