Use of Oral Probiotics as an Adjunctive Therapy to Fluconazole in the Treatment of Yeast Vaginitis
Recruitment status was: Recruiting
|First Submitted Date ICMJE||May 29, 2007|
|First Posted Date ICMJE||May 30, 2007|
|Last Update Posted Date||May 30, 2007|
|Start Date ICMJE||May 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||In the placebo group of patients, it is anticipated that at the 3 month period, a recurrence rate of 50% will occur, whereas, in the treatment arm a reduction in recurrence to 25% will be achieved [ Time Frame: 3 months ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||Reduction in clinic visits for urogenital care and cost savings [ Time Frame: 6 months ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Use of Oral Probiotics as an Adjunctive Therapy to Fluconazole in the Treatment of Yeast Vaginitis|
|Official Title ICMJE||A Double-Blind,Randomized Placebo-Controlled Study Using Probiotic Lactobacillus GR-1 and RC-14 as an Adjunctive Therapy to Fluconazole in the Treatment of Yeast Vaginitis|
|Brief Summary||Yeast vaginitis is a very common ailment affecting premenopausal women in Nigeria. This condition is more prevalent in the age group between 21-30 years. More than 75% of premenopausal women and university students are diagnosed with yeast infections annually. In most of these women, recurrent rate of vaginal candidiasis with empiric therapy, stands between 70 and 80%. In addition, resistance to anti-fungal agents is increasing at an alarming speed, particularly with species other than Candida albicans such as C tropicalis and C glabrata. The healthy vaginal environment is composed mainly of lactobacilli and when these organisms are suppressed overgrowth of a large number of pathogens occur including yeasts. In this pilot study,we hypothesize that oral administration of two well documented strains of lactobacilli (L.rhamnosis GR-1 and L.reuteri RC-14 ) given to women with recurrent yeast vaginitis, following standard therapy with fluconazole will result in a significant reduction in recurrence rate of the disease.|
STUDY HYPOTHESIS The administration of two well documented strains of lactobacilli (L.rhamnosis GR-1 and L.reuteri RC-14 ) given to women with recurrent yeast vaginitis, following standard therapy with fluconazole and compared with placebo will result in a significant reduction in recurrence rate of the disease.
Microscopic examination of vaginal secretion in 10% KOH for hyphae and mycelia Culture for fungal agent using Sabbraoud agar/broth.
• Participants randomised for age, history of previous (past year) yeast vaginitis.
Treatment Protocol 100 premenopausal women presenting with acute yeast vaginitis and a past history of 3 or 4 episodes of yeast vaginitis over the past 12 months will be treated with one oral dose of Fluconazole (Diflucan), then randomized into 2 groups:
Both groups of patients will be followed at 7days for proof of cure, 1 month, 2 months and 3 months following enrolment.
At all follow-up visits, the patients will be checked for symptoms and examined physically. Vaginal swabs will be tested for fungi microscopically and by culture, and BV organisms using Nugent scoring or with BV Blue test kit for vaginal sialidase.
Data to be collected
Vaginal swabs – two per visit:
In the placebo group of patients, it is anticipated that at the 3 month period, a recurrence rate of 50% will occur, whereas, in the treatment arm a reduction in recurrence to 25% will be achieved. The study is designed to have a power of 80% and to detect a reduction in recurrence at two-sided 5% significance level.
Subjects will be recruited from the women attending urogenital tract infection clinics at Faith Mediplex, Benin City.
Risk No risks are expected except the usual adverse effects associated with Fluconazole, otherwise probiotic lactobacilli are generally regarded as safe (GRAS) and no known side effects have been attributed to probiotic lactobacilli in immunocompetent individuals.
Benefits There may be benefits accruing from the probiotic arm of the study as recurrence rate may be low than the placebo. Also there may not be any direct benefit, but information gathered will help us in evaluating whether oral use of probiotics could be practically applicable in our environment against vaginal yeast infections.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Condition ICMJE||Vaginal Candidiasis|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||100|
|Estimated Completion Date||December 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Nigeria|
|Removed Location Countries|
|NCT Number ICMJE||NCT00479947|
|Other Study ID Numbers ICMJE||UB-CHr-N|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Faith Mediplex|
|PRS Account||Faith Mediplex|
|Verification Date||May 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP