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

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ClinicalTrials.gov Identifier: NCT02860845
Recruitment Status : Unknown
Verified August 2016 by Laboratorios Ordesa.
Recruitment status was:  Recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Study Start Date : July 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Boric acid and probiotics Device: Boric acid and probiotics
Vaginal capsules administered once a day during 7 days.

Active Comparator: Antibiotic/Antifungal 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 ]

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


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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


Contacts
Contact: Mireia Morera mireia.morera@ordesa.es
Contact: Marta Guarro marta.guarro@ordesa.es

Locations
Spain
Ginemed Sevilla Recruiting
Sevilla, Andalucía, Spain
Contact: Juan A Tena, Dr.         
Sponsors and Collaborators
Laboratorios Ordesa
Clever Instruments S.L.
Investigators
Principal Investigator: Juan A Tena, Dr. Ginemed Sevilla

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: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Candidiasis
Vaginal Diseases
Vaginosis, Bacterial
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