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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

Sponsor: Faith Mediplex
Collaborators: UrexBiotech
Information provided by: Faith Mediplex
Identifier: NCT00479947

Purpose

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 Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - 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 vagina. Exclusion Criteria: - 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

Investigators

  • 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. anukamkc@yahoo.com
  • Investigator: ALFRED AIYEBELEHIN, MBBS - Study Chair - Faith Mediplex

Locations

  • FaithMediplex

    Benin, Edo Nigeria

Conditions related to this trial:

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