Trial record 8 of 124 for:
vaginitis
Use of Oral Probiotics as an Adjunctive Therapy to Fluconazole in the Treatment of Yeast Vaginitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Faith Mediplex.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Faith Mediplex
Collaborators:
UrexBiotech
Chr Hansen A/S
Information provided by:
Faith Mediplex
ClinicalTrials.gov Identifier:
NCT00479947
First received: May 29, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vaginal Candidiasis |
Drug: Probiotics (Natural product) Drug: Probiotics (L. rhamnosus GR-1 and L. reuteri RC-14) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Faith Mediplex:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Reduction in clinic visits for urogenital care and cost savings [ Time Frame: 6 months ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2007 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 50 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479947
Contacts
| 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 |
Locations
| Nigeria | |
| FaithMediplex | Recruiting |
| Benin, Edo, Nigeria | |
| Principal Investigator: Chinonye C EZE-OKOROIKPA, MBBS | |
| Sub-Investigator: ALFRED AIYEBELEHIN, MBBS | |
| Sub-Investigator: Martin U Duru, MSc | |
Sponsors and Collaborators
Faith Mediplex
UrexBiotech
Chr Hansen A/S
Investigators
| 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00479947 History of Changes |
| Other Study ID Numbers: | UB-CHr-N |
| Study First Received: | May 29, 2007 |
| Last Updated: | May 29, 2007 |
| Health Authority: | Nigeria: The National Agency for Food and Drug Administration and Control |
Keywords provided by Faith Mediplex:
|
Yeast vaginitis Probiotics Lactobacilli Fluconazole |
Additional relevant MeSH terms:
|
Vaginitis Candidiasis Candidiasis, Vulvovaginal Mycoses Vulvovaginitis Vaginal Diseases Genital Diseases, Female Vulvitis Vulvar Diseases |
Fluconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013