Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479947
Status:
UNKNOWN
Last Update Posted:
2007-05-30
First Post:
2007-05-29
Brief Title:
Use of Oral Probiotics as an Adjunctive Therapy to Fluconazole in the Treatment of Yeast Vaginitis
Sponsor:
Faith Mediplex
Organization:
Faith Mediplex
Study Overview
Official Title:
A Double-BlindRandomized Placebo-Controlled Study Using Probiotic Lactobacillus GR-1 and RC-14 as an Adjunctive Therapy to Fluconazole in the Treatment of Yeast Vaginitis
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 studywe hypothesize that oral administration of two well documented strains of lactobacilli Lrhamnosis GR-1 and Lreuteri 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
Detailed Description:
STUDY HYPOTHESIS The administration of two well documented strains of lactobacilli Lrhamnosis GR-1 and Lreuteri 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 ie the participant must have identified herself as suffering from one or more of the following abnormalodourless 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 agarbroth
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
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 ie the participant must have identified herself as suffering from one or more of the following abnormalodourless 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 agarbroth
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None