Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.
Primary Purpose
Bacterial Vaginosis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Probiotic lactobacilli
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Bacterial Vaginosis
Eligibility 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.
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Probiotic lactobacilli
Placebo
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00752193
First Posted
September 11, 2008
Last Updated
November 18, 2021
Sponsor
University Ghent
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie
1. Study Identification
Unique Protocol Identification Number
NCT00752193
Brief Title
Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.
Official Title
Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 2008 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Probiotic lactobacilli
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Other
Intervention Name(s)
Probiotic lactobacilli
Intervention Description
Probiotic lactobacilli in combination with antibiotic therapy
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo in combination with antibiotic therapy
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marleen Temmerman, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
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Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.
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