- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00752193
Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.
November 18, 2021 updated by: University Ghent
Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
206
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ghent, Belgium, 9000
- University Hospital Ghent
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 2
Placebo
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Placebo in combination with antibiotic therapy
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Experimental: 1
Probiotic lactobacilli
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Probiotic lactobacilli in combination with antibiotic therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marleen Temmerman, MD, PhD, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2008
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
September 11, 2008
First Submitted That Met QC Criteria
September 12, 2008
First Posted (Estimate)
September 15, 2008
Study Record Updates
Last Update Posted (Actual)
November 19, 2021
Last Update Submitted That Met QC Criteria
November 18, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008/438
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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