Skip to main content
OpenTrials
Completed

NCT Number: NCT02860845

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ginemed Sevilla

Seville, Andalusia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Boric acid and probiotics

Device

Vaginal capsules administered once a day during 7 days.

Antibiotic (Clindamycin)

Drug

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

Other names: Clindamycin

Antifungal (Clotrimazole)

Drug

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

Other names: Clotrimazole

Primary outcomes

  1. Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.

    Time frame: 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)

Secondary outcomes

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

    Time frame: Baseline and 2 weeks after treatment finalization

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

  2. Number of Participants With Recurrent Infections

    Time frame: At 3 months after recruitment

    Descriptive of the proportion of patients with vulvovaginitis recurrence

Sponsors and collaborators

Lead sponsor

Laboratorios Ordesa

Industry

Collaborators

  • Clever Instruments S.L.

Registry information

Official study 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

Acronym: DOBO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.