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Use of Oral Probiotics as an Adjunctive Therapy to Fluconazole in the Treatment of Yeast Vaginitis

NCT00479947 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2007-05-30

No results posted yet for this study

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.

Conditions

  • Vaginal Candidiasis

Interventions

DRUG

Probiotics (Natural product)

DRUG

Probiotics (L. rhamnosus GR-1 and L. reuteri RC-14)

Sponsors & Collaborators

  • UrexBiotech

    collaborator UNKNOWN

  • Chr Hansen

    collaborator INDUSTRY

  • Faith Mediplex

    lead OTHER

Principal Investigators

  • Chinonye C EZE-OKOROIKPA, MBBS · Faith Mediplex

  • MARTIN U DURU, MSc · Faith Mediplex

  • KINGSLEY C ANUKAM, PhD · Benson Idahosa University, Benin City and Canadian R & D Centre for Probiotics, Lawson Health Research Intsitute, London, Ontario, Canada. [email protected]

  • ALFRED AIYEBELEHIN, MBBS · Faith Mediplex

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Completion
2007-12-31

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479947 on ClinicalTrials.gov