Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis
NCT ID: NCT00635622
Last Updated: 2009-07-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-04-30
Study Completion Date
2009-01-31
Brief Summary
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This is a phase IIa clinical trial in women with bacterial vaginosis. This study will determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found in normal vaginal flora.
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Detailed Description
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Phase IIa randomized, double blind, placebo-controlled, clinical trial of LACTIN-V at 2 x 10\^9 cfu/dose versus placebo, administered vaginally with a pre-filled applicator once daily for five consecutive days followed by a weekly dose over 2 additional weeks after an initial standardized antibiotic treatment with 0.75% topical metronidazole (MetroGel). A single site will enroll 40 participants (30 randomized to LACTIN-V and 10 to placebo).
Colonization rate of Lactobacillus crispatus CTV 05 will be assessed with culture and rep-PCR.
Safety will be determined by comparing the incidence of adverse events and serious adverse events in the LACTIN-V and placebo groups as determined by clinical symptoms, physical examination, pelvic examination with colposcopy and laboratory measurements. Tolerability will be measured by percentage of subjects who discontinue study product use due to overt adverse events and percentage of subjects who adhere to complete dosing schedule. Acceptability will be assessed via a standardized questionnaire and focus group discussions.
Colonization rate of Lactobacillus crispatus CTV 05 will be assessed with culture and rep-PCR.
Safety will be determined by comparing the incidence of adverse events and serious adverse events in the LACTIN-V and placebo groups as determined by clinical symptoms, physical examination, pelvic examination with colposcopy and laboratory measurements. Tolerability will be measured by percentage of subjects who discontinue study product use due to overt adverse events and percentage of subjects who adhere to complete dosing schedule. Acceptability will be assessed via a standardized questionnaire and focus group discussions.
Conditions
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Bacterial Vaginosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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1
Vaginal application of single-use applicators pre-filled with LACTIN-V (Formulation 1) at 2 x 10\^9 cfu/dose. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Group Type
EXPERIMENTAL
LACTIN-V
Intervention Type
DRUG
Vaginal application of single-use applicators pre-filled with LACTIN-V (Formulation 1) at 2 x 10\^9 cfu/dose or placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
2
Vaginal application of single-use applicators pre-filled with placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Group Type
PLACEBO_COMPARATOR
Placebo control substance
Intervention Type
DRUG
Vaginal application of single-use applicators pre-filled with placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Interventions
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LACTIN-V
Vaginal application of single-use applicators pre-filled with LACTIN-V (Formulation 1) at 2 x 10\^9 cfu/dose or placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Intervention Type
DRUG
Placebo control substance
Vaginal application of single-use applicators pre-filled with placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Untreated BV (asymptomatic or symptomatic) as diagnosed during the screening visit using Amsel criteria AND confirmed in the laboratory using the Nugent scoring system (Nugent Score ≥ 7).
* Otherwise healthy pre-menopausal women 18-40 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 pre-filled 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.
* Vaginal and cervical anatomy that in the opinion of the Investigator lends itself easily to colposcopy.
* Capable of reading and writing English and providing informed consent.
* Previous sexual experience including vaginal intercourse.
* Previous gynecological examinations.
* Currently in a mutually monogamous sexual relationship or not sexually active.
* Agree to be sexually abstinent 72 hours prior to Visit 1 (enrollment) until Visit 2 (Day 10). Also, agree to refrain from intercourse for 48 hours after the study product application on Day 12 and 19 as well as 72 hours before the last study visit on Day 28.
* 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, from the time of screening until Day 28.
* Agree to abstain from using tampons throughout the trial period, from the time of screening until Day 28.
* 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.
* Otherwise healthy pre-menopausal women 18-40 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 pre-filled 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.
* Vaginal and cervical anatomy that in the opinion of the Investigator lends itself easily to colposcopy.
* Capable of reading and writing English and providing informed consent.
* Previous sexual experience including vaginal intercourse.
* Previous gynecological examinations.
* Currently in a mutually monogamous sexual relationship or not sexually active.
* Agree to be sexually abstinent 72 hours prior to Visit 1 (enrollment) until Visit 2 (Day 10). Also, agree to refrain from intercourse for 48 hours after the study product application on Day 12 and 19 as well as 72 hours before the last study visit on Day 28.
* 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, from the time of screening until Day 28.
* Agree to abstain from using tampons throughout the trial period, from the time of screening until Day 28.
* 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 30 days of Enrollment visit.
* Investigational drug use within 30 days 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 (\> 3months) 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 60 days.
* Previous participation in a L. crispatus CTV-05 clinical study.
* Colposcopic findings at the enrollment visit involving significant deep disruption of the epithelium.
* Known allergy to any component of LACTIN-V, other significant drug allergy 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.
* 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 30 days of Enrollment visit.
* Investigational drug use within 30 days 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 (\> 3months) 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 60 days.
* Previous participation in a L. crispatus CTV-05 clinical study.
* Colposcopic findings at the enrollment visit involving significant deep disruption of the epithelium.
* Known allergy to any component of LACTIN-V, other significant drug allergy 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
40 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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University of California, San Francisco
OTHER
Sponsor Role
collaborator
Osel, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Osel, Inc.
Principal Investigators
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Craig R Cohen, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Anke Hemmerling, MD, MPH, PhD
Role: STUDY_DIRECTOR
University of California, San Francisco
Locations
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San Francisco General Hospital (SFGH), University of California, San Francisco (UCSF)
San Francisco, California, United States
Site Status
Countries
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United States
References
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Myer L, Denny L, Telerant R, Souza Md, Wright TC Jr, Kuhn L. Bacterial vaginosis and susceptibility to HIV infection in South African women: a nested case-control study. J Infect Dis. 2005 Oct 15;192(8):1372-80. doi: 10.1086/462427. Epub 2005 Sep 9.
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Hay P. Recurrent Bacterial Vaginosis. Curr Infect Dis Rep. 2000 Dec;2(6):506-512. doi: 10.1007/s11908-000-0053-5.
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Bradshaw CS, Morton AN, Hocking J, Garland SM, Morris MB, Moss LM, Horvath LB, Kuzevska I, Fairley CK. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis. 2006 Jun 1;193(11):1478-86. doi: 10.1086/503780. Epub 2006 Apr 26.
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Myer L, Kuhn L, Denny L, Wright TC Jr. Recurrence of symptomatic bacterial vaginosis 12 months after oral metronidazole therapy in HIV-positive and -negative women. J Infect Dis. 2006 Dec 15;194(12):1797-9. doi: 10.1086/509625. No abstract available.
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Hughes VL, Hillier SL. Microbiologic characteristics of Lactobacillus products used for colonization of the vagina. Obstet Gynecol. 1990 Feb;75(2):244-8.
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Chimura T, Funayama T, Murayama K, Numazaki M. [Ecological treatment of bacterial vaginosis]. Jpn J Antibiot. 1995 Mar;48(3):432-6. Japanese.
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BACKGROUND
Fredricks DN, Fiedler TL, Thomas KK, Oakley BB, Marrazzo JM. Targeted PCR for detection of vaginal bacteria associated with bacterial vaginosis. J Clin Microbiol. 2007 Oct;45(10):3270-6. doi: 10.1128/JCM.01272-07. Epub 2007 Aug 8.
Reference Type
BACKGROUND
Ngugi BM, Hemmerling A, Bukusi EA, Kikuvi G, Gikunju J, Shiboski S, Fredricks DN, Cohen CR. Effects of bacterial vaginosis-associated bacteria and sexual intercourse on vaginal colonization with the probiotic Lactobacillus crispatus CTV-05. Sex Transm Dis. 2011 Nov;38(11):1020-7. doi: 10.1097/OLQ.0b013e3182267ac4.
Reference Type
DERIVED
Hemmerling A, Harrison W, Schroeder A, Park J, Korn A, Shiboski S, Foster-Rosales A, Cohen CR. Phase 2a study assessing colonization efficiency, safety, and acceptability of Lactobacillus crispatus CTV-05 in women with bacterial vaginosis. Sex Transm Dis. 2010 Dec;37(12):745-50. doi: 10.1097/OLQ.0b013e3181e50026.
Reference Type
DERIVED
Other Identifiers
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LV-006
Identifier Type: -
Identifier Source: org_study_id
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NCT01232595
COMPLETED
PHASE2
Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis
NCT03357666
UNKNOWN
PHASE2
Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus Intestinal Carriage
NCT00437580
UNKNOWN
PHASE4
Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Via Capsules for Intestinal Multidrug-resistant Bacteria Decolonization
NCT07106580
RECRUITING
PHASE1/PHASE2
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
NCT00153517
COMPLETED
PHASE2
Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile.
NCT00377078
UNKNOWN
NA
Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Infections
NCT05606159
WITHDRAWN
NA
Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection
NCT00304356
COMPLETED
PHASE3
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
NCT01259726
COMPLETED
PHASE2
Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection
NCT02686645
UNKNOWN
PHASE2/PHASE3
Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin
NCT07221708
NOT_YET_RECRUITING
PHASE2/PHASE3
Clostridioides Difficile Controlled Human Infection Model
NCT06702345
NOT_YET_RECRUITING
NA
Oral Vaccination Against Clostridium Difficile Infection
NCT02991417
TERMINATED
PHASE1
Pilot Study Using Oral Capsule FMT to Decolonize GI CRE
NCT03527056
WITHDRAWN
EARLY_PHASE1
Treatment of BV With Donaxyl and a Molecular Test of Cure
NCT04057482
COMPLETED
Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis
NCT00417872
COMPLETED
PHASE2