Candidiasis Clinical Trial
— DOBOOfficial 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
Verified date | November 2019 |
Source | Laboratorios Ordesa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 48 |
Est. completion date | November 30, 2017 |
Est. primary completion date | October 16, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Ginemed Sevilla | Sevilla | Andalucía |
Lead Sponsor | Collaborator |
---|---|
Laboratorios Ordesa | Clever Instruments S.L. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | 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) | Baseline and at 2 weeks after treatment finalization | |
Secondary | Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. | Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures. | Baseline and 2 weeks after treatment finalization | |
Secondary | Number of Participants With Recurrent Infections | Descriptive of the proportion of patients with vulvovaginitis recurrence | At 3 months after recruitment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01982071 -
A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
|
Phase 4 | |
Completed |
NCT02391532 -
Effect of Probiotic Bacteria on Oral Candida in Frail Elderly
|
N/A | |
Completed |
NCT01447407 -
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
|
Phase 1 | |
Not yet recruiting |
NCT00889356 -
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
|
Phase 3 | |
Completed |
NCT00105144 -
Study of Micafungin in Patients With Invasive Candidiasis or Candidemia
|
Phase 3 | |
Completed |
NCT00163111 -
A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood.
|
Phase 3 | |
Completed |
NCT00138502 -
Funguria in Hospitalized Patients
|
||
Not yet recruiting |
NCT04502277 -
Bioavailability of Flucanazole
|
Early Phase 1 | |
Completed |
NCT03203551 -
Clinical and Laboratorial Evaluation of the Desinfection Solutions in Candida Species From Total Prostheses and Palate of Total Edentulous.
|
N/A | |
Completed |
NCT05044156 -
Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
|
||
Completed |
NCT01322698 -
Staging Candidiasis in ICU Patients
|
N/A | |
Terminated |
NCT01092832 -
A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients
|
Phase 3 | |
Terminated |
NCT00095316 -
Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
|
Phase 3 | |
Completed |
NCT04122560 -
Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration
|
Phase 4 | |
Completed |
NCT02641717 -
Validity of Patient-Collected Wet Mounts
|
N/A | |
Recruiting |
NCT01253954 -
A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China
|
N/A | |
Completed |
NCT00734539 -
Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight
|
Phase 3 | |
Completed |
NCT00797420 -
Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers
|
Phase 1 | |
Completed |
NCT00001937 -
Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients
|
Phase 3 | |
Completed |
NCT02666716 -
Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients
|