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

NCT00479947 | Unknown Phase 1

• 1 other identifier: UB-CHr-N
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Keywords

Yeast vaginitis; Probiotics; Lactobacilli; Fluconazole

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (1)

• Reduction in clinic visits for urogenital care and cost savings

  6 months

Interventions

Probiotics (Natural product) DRUG

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Faith Mediplex: lead
• UrexBiotech: collaborator
• Chr Hansen: collaborator

Study Sites (1)

FaithMediplex

Benin City, Edo, Nigeria

RECRUITING

Related Publications (2)

• Falagas ME, Betsi GI, Athanasiou S. Probiotics for prevention of recurrent vulvovaginal candidiasis: a review. J Antimicrob Chemother. 2006 Aug;58(2):266-72. doi: 10.1093/jac/dkl246. Epub 2006 Jun 21.

  PMID: 16790461 BACKGROUND

• 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. doi: 10.1016/s0025-7753(01)72089-1. Spanish.

  PMID: 11571120 BACKGROUND

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Probiotics; Biological Products

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Complex Mixtures

Study Officials

• Chinonye C EZE-OKOROIKPA, MBBS

  Faith Mediplex

  STUDY CHAIR

• MARTIN U DURU, MSc

  Faith Mediplex

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• ALFRED AIYEBELEHIN, MBBS

  Faith Mediplex

  STUDY CHAIR

Central Study Contacts

Martin U Duru, MSc

CONTACT

234+8056650828; durumartin@yahoo.co.uk

Kingsley C Anukam, PhD, MHPM

CONTACT

519-646-6000; anukamkc@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2007
• First Posted: May 30, 2007
• Study Start: May 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 30, 2007

Record last verified: 2007-05

Locations

NG (1)