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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
This study is currently Recruiting
May 2007 By Faith Mediplex
First Recieved on May 29, 2007
Last Updated on May 29, 2007
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.
||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Drug:Probiotics (Natural product)|
|Drug:Probiotics (L. rhamnosus GR-1 and L. reuteri RC-14)|
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Premenopausal women suffering from acute or chronic yeast vaginitis and a past
history of 3 or 4 episodes over the 12 months will be selected.
- All participants must be symptomatic, i.e. the participant must have identified
herself as suffering from one or more of the following: abnormal/odourless vaginal
discharge, dyspareunia or dysuria, localized irritation or discomfort around the
- Participants must not be suffering from other urogenital infections or conditions
such as HIV that will potentially alter their response to disease. Participants will
be tested and excluded for the presence of Trichomonas vaginalis and Bacterial
vaginosis at inclusion. Other conditions will be ruled out on the basis of medical
history and clinical assessment.
- Participants must not be pregnant.
- Participants must not be younger than 18 or older than 50 years.
- Participants must not be menstruating during diagnosis or treatment
- Investigator: Chinonye C EZE-OKOROIKPA, MBBS - Study Chair - Faith Mediplex
- Investigator: MARTIN U DURU, MSc - Study Director - Faith Mediplex
- Investigator: KINGSLEY C ANUKAM, PhD - Principal Investigator - Benson Idahosa University, Benin City and Canadian R & D Centre for Probiotics, Lawson Health Research Intsitute, London, Ontario, Canada. firstname.lastname@example.org
- Investigator: ALFRED AIYEBELEHIN, MBBS - Study Chair - Faith Mediplex
Benin, Edo Nigeria