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Sponsors and Collaborators: |
Faith Mediplex UrexBiotech Chr-Hansen |
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Information provided by: | Faith Mediplex |
ClinicalTrials.gov Identifier: | NCT00479947 |
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.
Condition | Intervention | Phase |
---|---|---|
Vaginal Candidiasis |
Drug: Probiotics (Natural product) Drug: Probiotics (L. rhamnosus GR-1 and L. reuteri RC-14) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 100 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
abnormal/odourless vaginal discharge, dyspareunia or dysuria, localized irritation or discomfort around the vagina.
Exclusion Criteria:
Contact: Martin U Duru, MSc | 234+8056650828 | durumartin@yahoo.co.uk |
Contact: Kingsley C Anukam, PhD, MHPM | 519-646-6000 ext 61547 | anukamkc@yahoo.com |
Nigeria, Edo | |
FaithMediplex | Recruiting |
Benin, Edo, Nigeria | |
Principal Investigator: Chinonye C EZE-OKOROIKPA, MBBS | |
Sub-Investigator: ALFRED AIYEBELEHIN, MBBS | |
Sub-Investigator: Martin U Duru, MSc |
Study Chair: | Chinonye C EZE-OKOROIKPA, MBBS | Faith Mediplex |
Study Director: | MARTIN U DURU, MSc | Faith Mediplex |
Principal Investigator: | KINGSLEY C ANUKAM, PhD | Benson Idahosa University, Benin City and Canadian R & D Centre for Probiotics, Lawson Health Research Intsitute, London, Ontario, Canada. anukamkc@yahoo.com |
Study Chair: | ALFRED AIYEBELEHIN, MBBS | Faith Mediplex |
Study ID Numbers: | UB-CHr-N |
Study First Received: | May 29, 2007 |
Last Updated: | May 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00479947 History of Changes |
Health Authority: | Nigeria: The National Agency for Food and Drug Administration and Control |
Yeast vaginitis Probiotics Lactobacilli Fluconazole |
Fluconazole Vulvovaginitis Candidiasis Candidiasis, Vulvovaginal Clotrimazole Miconazole Vaginitis |
Tioconazole Vaginal Diseases Genital Diseases, Female Mycoses Antifungal Agents Vulvar Diseases |
Fluconazole Vulvovaginitis Anti-Infective Agents Candidiasis Candidiasis, Vulvovaginal Vaginitis Vaginal Diseases |
Pharmacologic Actions Genital Diseases, Female Mycoses Antifungal Agents Therapeutic Uses Vulvitis Vulvar Diseases |