Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860845
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Clever Instruments S.L.
Information provided by (Responsible Party):
Laboratorios Ordesa

Brief 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).

Condition or disease Intervention/treatment Phase
Candidiasis Vaginosis, Bacterial Device: Boric acid and probiotics Drug: Antibiotic (Clindamycin) Drug: Antifungal (Clotrimazole) Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 12, 2016
Actual Primary Completion Date : October 16, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


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 Name: Clindamycin

Drug: Antifungal (Clotrimazole)
Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
Other Name: Clotrimazole




Primary Outcome Measures :
  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 and stinging are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3)


Secondary Outcome Measures :
  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. vaginal discharge

  2. Number of recurrent infections rate determined by medical evaluation of clinical symptoms. [ Time Frame: At 3 months after recruitment ]
    Record of number of infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860845


Locations
Layout table for location information
Spain
Ginemed Sevilla
Sevilla, Andalucía, Spain
Sponsors and Collaborators
Laboratorios Ordesa
Clever Instruments S.L.
Investigators
Layout table for investigator information
Principal Investigator: Juan A Tena, Dr. Ginemed Sevilla

Layout table for additonal information
Responsible Party: Laboratorios Ordesa
ClinicalTrials.gov Identifier: NCT02860845     History of Changes
Other Study ID Numbers: DOBO-01-16
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Candidiasis
Vaginosis, Bacterial
Vaginal Diseases
Mycoses
Genital Diseases, Female
Bacterial Infections
Vaginitis
Anti-Bacterial Agents
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Antibiotics, Antitubercular
Miconazole
Antifungal Agents
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors