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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Faith Mediplex.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00479947
First Posted: May 30, 2007
Last Update Posted: May 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
UrexBiotech
Chr Hansen
Information provided by:
Faith Mediplex
May 29, 2007
May 30, 2007
May 30, 2007
May 2007
Not Provided
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 ]
Same as current
No Changes Posted
Reduction in clinic visits for urogenital care and cost savings [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Use of Oral Probiotics as an Adjunctive Therapy to Fluconazole in the Treatment of Yeast Vaginitis
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
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 HYPOTHESIS The 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 and compared with placebo will result in a significant reduction in recurrence rate of the disease.

Methodology

Study participants

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

Laboratory Diagnosis:

Microscopic examination of vaginal secretion in 10% KOH for hyphae and mycelia Culture for fungal agent using Sabbraoud agar/broth.

Randomisation:

• Participants randomised for age, history of previous (past year) yeast vaginitis.

Treatment Protocol 100 premenopausal women presenting with acute yeast vaginitis and a past history of 3 or 4 episodes of yeast vaginitis over the past 12 months will be treated with one oral dose of Fluconazole (Diflucan), then randomized into 2 groups:

  • Group A: Receiving one oral dose of Fluconazole + oral placebo capsules for 3 months.
  • Group B: Receiving one oral dose of Fluconazole + capsules of L. rhamnosus GR-1 and L reuteri RC-14 containing 5 billion live organisms for 3 months.

Both groups of patients will be followed at 7days for proof of cure, 1 month, 2 months and 3 months following enrolment.

At all follow-up visits, the patients will be checked for symptoms and examined physically. Vaginal swabs will be tested for fungi microscopically and by culture, and BV organisms using Nugent scoring or with BV Blue test kit for vaginal sialidase.

Data to be collected

Symptoms:

  • Lifestyle questionnaire, to include daily self-assessment of presence and severity of condition (discharge, irritation,) for the first 7 days. To include self-determined definition of when recovery begins and when it is complete. Also include menstrual cycle information (during the treatment, is the subject in early, mid or late cycle?).
  • Physician assessment at each visit.

Vaginal swabs – two per visit:

  • Day 0 (before treatment)
  • Day 7 (Proof of cure for the two groups).

    • 1 month after treatment
    • 2 months after treatment
    • 3 months after treatment.

Statistical Analysis

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. The study is designed to have a power of 80% and to detect a reduction in recurrence at two-sided 5% significance level.

Participants Recruitment:

Subjects will be recruited from the women attending urogenital tract infection clinics at Faith Mediplex, Benin City.

Risk No risks are expected except the usual adverse effects associated with Fluconazole, otherwise probiotic lactobacilli are generally regarded as safe (GRAS) and no known side effects have been attributed to probiotic lactobacilli in immunocompetent individuals.

Benefits There may be benefits accruing from the probiotic arm of the study as recurrence rate may be low than the placebo. Also there may not be any direct benefit, but information gathered will help us in evaluating whether oral use of probiotics could be practically applicable in our environment against vaginal yeast infections.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Vaginal Candidiasis
  • Drug: Probiotics (Natural product)
  • Drug: Probiotics (L. rhamnosus GR-1 and L. reuteri RC-14)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
December 2007
Not Provided

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Nigeria
 
 
NCT00479947
UB-CHr-N
No
Not Provided
Not Provided
Not Provided
Faith Mediplex
  • UrexBiotech
  • Chr Hansen
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
Faith Mediplex
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP