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

First Received on May 29, 2007. No Changes Posted

Sponsor:	Faith Mediplex
Collaborators:	UrexBiotech Chr Hansen A/S
Information provided by:	Faith Mediplex
ClinicalTrials.gov Identifier:	NCT00479947

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 I

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:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Fluconazole

U.S. FDA Resources

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:

Falagas ME, Betsi GI, Athanasiou S. Probiotics for prevention of recurrent vulvovaginal candidiasis: a review. J Antimicrob Chemother. 2006 Aug;58(2):266-72. Epub 2006 Jun 21. Review.

Osset J, Garcia E, Bartolome RM, Andreu A. [Role of Lactobacillus as protector against vaginal candidiasis] Med Clin (Barc). 2001 Sep 22;117(8):285-8. Spanish.

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:

Candidiasis
Candidiasis, Vulvovaginal
Vaginitis
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 February 09, 2012