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Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.
This study is not yet open for participant recruitment.
Verified by University Ghent, September 2008
Sponsors and Collaborators: University Ghent
IWT
Information provided by: University Ghent
ClinicalTrials.gov Identifier: NCT00752193
  Purpose

The purpose of this study is to assess the safety and the efficacy of vaginally administered probiotic lactobacilli in combination with antibiotic therapy (metronidazole) in women with microbiologically defined bacterial vaginosis.


Condition Intervention
Bacterial Vaginosis
Other: Probiotic lactobacilli
Other: Placebo

U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • The proposed research project aims at the development of a vaginal probiotic delivery system to restore and to maintain the vaginal microflora [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 206
Study Start Date: October 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Probiotic lactobacilli
Other: Probiotic lactobacilli
Probiotic lactobacilli in combination with antibiotic therapy
2: Placebo Comparator
Placebo
Other: Placebo
Placebo in combination with antibiotic therapy

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Untreated Bacterial Vaginosis (BV) (asymptomatic or symptomatic) as diagnosed during the screening visit using Amsel criteria.
  • Otherwise healthy? pre-menopausal women between 18-50 years of age at date of screening.
  • Regular menstrual cycles (21-35 days) or amenorrheic for at least 3 months due to use of a long acting progestin or continuous use of oral contraceptives.
  • Subject is willing to insert vaginal applicators.
  • Subject is willing to be asked questions about personal medical health and sexual history
  • Normal Pap smear collected at the screening visit? If a subject's Visit 0 Pap smear result is any of the following, the person is ineligible for participation: ASC-US (atypical squamous cells of undetermined significance), AGC (atypical glandular cells), ASC-H (atypical squamous cells, cannot r/o high grade lesion), LSIL (low grade squamous intraepithelial lesions), HSIL (high grade squamous intraepithelial lesions), adenocarcinoma in situ, adenocarcinoma, squamous cell carcinoma in situ, squamous cell carcinoma or inadequate sample
  • Agree to be sexually abstinent 48 hours prior to Visit 1 (enrollment) until 48 hours after application of the study product and a second time after visit 2.
  • Agree to abstain from the use of any other intravaginal product (i.e., contraceptive creams, gels, foams, sponges, lubricants, douches, etc.) throughout the trial period.
  • Agree to use an adequate method of birth control for the duration of the study to avoid pregnancy. Acceptable methods include a history of tubal ligation, male partner with a vasectomy, a steroidal contraceptive (oral, patch, injectable or implantable), IUD (Paragard or Mirena), condoms or abstinence.
  • Subject must have access to functioning refrigerator.

Exclusion Criteria:

  • Urogenital infection at screening or within the 21 days prior to screening. This includes urinary tract infection, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis or Treponema pallidum. Subjects may be re-screened at least 21 days after the respective antibiotic or antifungal therapies have been completed.
  • History of recurrent genital herpes.
  • Diagnosis of N. gonorrhoeae, C. trachomatis, T. pallidum or T. vaginalis on two or more occasions during the six months prior to screening.
  • Pregnancy or within 2 months of last pregnancy (all subjects will have a urine pregnancy test prior to enrollment).
  • Lactation.
  • Vaginal or systemic antibiotic or antifungal therapy within 21 days of the Screening visit or within 4 months of Enrollment visit.
  • Investigational drug use within 4 months or 10 half-lives of the drug, whichever is longer, of enrollment visit. Planned investigational drug use while participating in this study.
  • Menopause.
  • IUD insertion or removal within the last 3 months.
  • Pelvic surgery within the last 3 months.
  • Cervical cryotherapy or cervical laser within the last 3 months.
  • Use of a NuvaRing® within 3 days of the screening visit or during the course of the study.
  • New long-acting treatments (e.g. depot formulation including medroxyprogesterone acetate (DMPA) form of hormonal birth control). Subjects may be enrolled if stable (> 3 months) on existing therapy as determined by the Principal Investigator.
  • Diabetes or other significant disease or acute illness that in the Investigator's assessment could complicate the evaluation.
  • Known HIV infection or positive HIV test at screening.
  • Immunosuppressive drug within 4 months.
  • Previous participation in a L. crispatus clinical study.
  • Colposcopic findings at the enrollment visit involving significant deep disruption of the epithelium.
  • Known allergy to any component (skim milk,…) of the drug or to latex (condoms).
  • Unavailable for follow-up visits.
  • History of drug or alcohol abuse.
  • At enrollment, have any social or medical condition, or psychiatric illness that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752193

Contacts
Contact: Marleen Temmerman, MD, PhD Marleen.temmerman@ugent.be

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
IWT
Investigators
Principal Investigator: Marleen Temmerman, MD, PhD University Hospital, Ghent
  More Information

Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

Responsible Party: University Ghent ( Marleen Temmerman )
Study ID Numbers: 2008/438
Study First Received: September 11, 2008
Last Updated: September 12, 2008
ClinicalTrials.gov Identifier: NCT00752193  
Health Authority: Belgium: Institutional Review Board

Study placed in the following topic categories:
Genital Diseases, Female
Bacterial Infections
Vaginosis, Bacterial
Vaginitis
Vaginal Diseases

ClinicalTrials.gov processed this record on January 16, 2009