Bacterial VaginosisPhase 2NCT00635622
Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis
A Phase 2 study testing LACTIN-V in people with Bacterial Vaginosis, run by Osel, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- LACTIN-V
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital (SFGH), University of California, San Francisco (UCSF)
San Francisco, California, 94110
About this study
Official title: A Phase IIa Study of the Colonization Efficiency, Safety and Acceptability of LACTIN-V Administered Vaginally to Women With Bacterial Vaginosis
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.
Read the detailed description
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.
- Conditions
- Bacterial Vaginosis
- Being tested
- LACTIN-V, Placebo control substance
- Keywords
- Bacterial Vaginosis, BV, UCSF, SFGH
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACTIN-VDrug
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.
Placebo control substanceDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Drug: LACTIN-V |
| 2 | Placebo comparator | 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. Receives: Drug: Placebo control substance |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the vaginal colonization efficiency of L. crispatus CTV-05 after vaginal administration of LACTIN-V at 2 x 10^9 cfu/dose (600 mg) daily for 5 days followed by weekly applications over 2 additional weeks
Measured: 4 weeks after intervention
Secondary outcomes (6)
To evaluate the safety of L. crispatus, LACTIN-V in otherwise healthy pre-menopausal women with BV, immediately after standardized antibiotic treatment with 0.75% topical metronidazole
Measured: 10 days and 4 weeks after intervention
To evaluate the tolerability and acceptability of LACTIN-V as a powder in a pre-filled applicator
Measured: 4 weeks after intervention
To evaluate and compare vaginal flora by Gram stain before and after receipt of LACTIN-V or placebo.
Measured: 10 days and 4 weeks after intervention
To identify and compare bacteria colonizing the vagina at screening in women with bacterial vaginosis and after antibiotic and probiotic treatment.
Measured: Before intervention and 4 weeks after intervention
To measure and compare the 4 week cure rate of BV after receipt of MetroGel in women who receive LACTIN-V or placebo.
Measured: 4 weeks after intervention
To measure the rate of vaginal colonization by Candida sp. and symptomatic vaginal candidiasis after receiving LACTIN-V or placebo
Measured: 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Investigators
- Craig R Cohen, MD, MPH, Principal investigator, University of California, San FranciscoAnke Hemmerling, MD, MPH, PhD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635622
- Sponsor's protocol ID
- LV-006
- Status last verified
- Mar 2009
- First submitted
- 10 Mar 2008
- Last updated
- 10 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Giorgi A, Torriani S, Dellaglio F, Bo G, Stola E, Bernuzzi L. Identification of vaginal lactobacilli from asymptomatic women. Microbiologica. 1987 Oct;10(4):377-84.
PubMed 3695985Antonio MA, Hawes SE, Hillier SL. The identification of vaginal Lactobacillus species and the demographic and microbiologic characteristics of women colonized by these species. J Infect Dis. 1999 Dec;180(6):1950-6. doi: 10.1086/315109.
PubMed 10558952Antonio MA, Hillier SL. DNA fingerprinting of Lactobacillus crispatus strain CTV-05 by repetitive element sequence-based PCR analysis in a pilot study of vaginal colonization. J Clin Microbiol. 2003 May;41(5):1881-7. doi: 10.1128/JCM.41.5.1881-1887.2003.
PubMed 12734221Sobel JD. Vaginitis in adult women. Obstet Gynecol Clin North Am. 1990 Dec;17(4):851-79.
PubMed 2092246Thomason JL, Gelbart SM, Scaglione NJ. Bacterial vaginosis: current review with indications for asymptomatic therapy. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 2):1210-7. doi: 10.1016/s0002-9378(12)90729-2.
PubMed 1951577Pastore LM, Thorp JM Jr, Royce RA, Savitz DA, Jackson TP. Risk score for antenatal bacterial vaginosis: BV PIN points. J Perinatol. 2002 Mar;22(2):125-32. doi: 10.1038/sj.jp.7210654.
PubMed 11896517Kamara P, Hylton-Kong T, Brathwaite A, Del Rosario GR, Kristensen S, Patrick N, Weiss H, Figueroa PJ, Vermund SH, Jolly PE. Vaginal infections in pregnant women in Jamaica: prevalence and risk factors. Int J STD AIDS. 2000 Aug;11(8):516-20. doi: 10.1258/0956462001916425.
PubMed 10990336Gibney L, Macaluso M, Kirk K, Hassan MS, Schwebke J, Vermund SH, Choudhury P. Prevalence of infectious diseases in Bangladeshi women living adjacent to a truck stand: HIV/STD/hepatitis/genital tract infections. Sex Transm Infect. 2001 Oct;77(5):344-50. doi: 10.1136/sti.77.5.344.
PubMed 11588280Goldenberg RL, Klebanoff MA, Nugent R, Krohn MA, Hillier S, Andrews WW. Bacterial colonization of the vagina during pregnancy in four ethnic groups. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1996 May;174(5):1618-21. doi: 10.1016/s0002-9378(96)70617-8.
PubMed 9065140Sewankambo N, Gray RH, Wawer MJ, Paxton L, McNaim D, Wabwire-Mangen F, Serwadda D, Li C, Kiwanuka N, Hillier SL, Rabe L, Gaydos CA, Quinn TC, Konde-Lule J. HIV-1 infection associated with abnormal vaginal flora morphology and bacterial vaginosis. Lancet. 1997 Aug 23;350(9077):546-50. doi: 10.1016/s0140-6736(97)01063-5.
PubMed 9284776Allsworth JE, Peipert JF. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstet Gynecol. 2007 Jan;109(1):114-20. doi: 10.1097/01.AOG.0000247627.84791.91.
PubMed 17197596Hay PE, Lamont RF, Taylor-Robinson D, Morgan DJ, Ison C, Pearson J. Abnormal bacterial colonisation of the genital tract and subsequent preterm delivery and late miscarriage. BMJ. 1994 Jan 29;308(6924):295-8. doi: 10.1136/bmj.308.6924.295.
PubMed 8124116Eschenbach DA. Bacterial vaginosis and anaerobes in obstetric-gynecologic infection. Clin Infect Dis. 1993 Jun;16 Suppl 4:S282-7. doi: 10.1093/clinids/16.supplement_4.s282.
PubMed 8324132Hawes SE, Hillier SL, Benedetti J, Stevens CE, Koutsky LA, Wolner-Hanssen P, Holmes KK. Hydrogen peroxide-producing lactobacilli and acquisition of vaginal infections. J Infect Dis. 1996 Nov;174(5):1058-63. doi: 10.1093/infdis/174.5.1058.
PubMed 8896509Puapermpoonsiri S, Kato N, Watanabe K, Ueno K, Chongsomchai C, Lumbiganon P. Vaginal microflora associated with bacterial vaginosis in Japanese and Thai pregnant women. Clin Infect Dis. 1996 Oct;23(4):748-52. doi: 10.1093/clinids/23.4.748.
PubMed 8909838
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study of the Colonization Efficiency, Safety and Acceptability of LACTIN-V Administered Vaginally to Women With Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT00635622
- Acronym / sponsor ID
- LV-006
- Conditions
- Bacterial Vaginosis
- Keywords
- Bacterial Vaginosis, BV, UCSF, SFGH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Osel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LACTIN-VVaginal 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. |
| 2 | Placebo comparator | Drug: Placebo control substanceVaginal 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LACTIN-VVaginal 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. | Drug | 1 |
| Placebo control substanceVaginal 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. | Drug | 2 |
Primary outcome
To evaluate the vaginal colonization efficiency of L. crispatus CTV-05 after vaginal administration of LACTIN-V at 2 x 10^9 cfu/dose (600 mg) daily for 5 days followed by weekly applications over 2 additional weeks
Time frame: 4 weeks after intervention
6 secondary outcomes
To evaluate the safety of L. crispatus, LACTIN-V in otherwise healthy pre-menopausal women with BV, immediately after standardized antibiotic treatment with 0.75% topical metronidazole
Time frame: 10 days and 4 weeks after intervention
To evaluate the tolerability and acceptability of LACTIN-V as a powder in a pre-filled applicator
Time frame: 4 weeks after intervention
To evaluate and compare vaginal flora by Gram stain before and after receipt of LACTIN-V or placebo.
Time frame: 10 days and 4 weeks after intervention
To identify and compare bacteria colonizing the vagina at screening in women with bacterial vaginosis and after antibiotic and probiotic treatment.
Time frame: Before intervention and 4 weeks after intervention
To measure and compare the 4 week cure rate of BV after receipt of MetroGel in women who receive LACTIN-V or placebo.
Time frame: 4 weeks after intervention
To measure the rate of vaginal colonization by Candida sp. and symptomatic vaginal candidiasis after receiving LACTIN-V or placebo
Time frame: 4 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2009.
- Background: PubMed 3695985Giorgi A, Torriani S, Dellaglio F, Bo G, Stola E, Bernuzzi L. Identification of vaginal lactobacilli from asymptomatic women. Microbiologica. 1987 Oct;10(4):377-84.
- Background: PubMed 10558952Antonio MA, Hawes SE, Hillier SL. The identification of vaginal Lactobacillus species and the demographic and microbiologic characteristics of women colonized by these species. J Infect Dis. 1999 Dec;180(6):1950-6. doi: 10.1086/315109.
- Background: PubMed 12734221Antonio MA, Hillier SL. DNA fingerprinting of Lactobacillus crispatus strain CTV-05 by repetitive element sequence-based PCR analysis in a pilot study of vaginal colonization. J Clin Microbiol. 2003 May;41(5):1881-7. doi: 10.1128/JCM.41.5.1881-1887.2003.
- Background: PubMed 2092246Sobel JD. Vaginitis in adult women. Obstet Gynecol Clin North Am. 1990 Dec;17(4):851-79.
- Background: PubMed 1951577Thomason JL, Gelbart SM, Scaglione NJ. Bacterial vaginosis: current review with indications for asymptomatic therapy. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 2):1210-7. doi: 10.1016/s0002-9378(12)90729-2.
- Background: PubMed 11896517Pastore LM, Thorp JM Jr, Royce RA, Savitz DA, Jackson TP. Risk score for antenatal bacterial vaginosis: BV PIN points. J Perinatol. 2002 Mar;22(2):125-32. doi: 10.1038/sj.jp.7210654.
- Background: PubMed 10990336Kamara P, Hylton-Kong T, Brathwaite A, Del Rosario GR, Kristensen S, Patrick N, Weiss H, Figueroa PJ, Vermund SH, Jolly PE. Vaginal infections in pregnant women in Jamaica: prevalence and risk factors. Int J STD AIDS. 2000 Aug;11(8):516-20. doi: 10.1258/0956462001916425.
- Background: PubMed 11588280Gibney L, Macaluso M, Kirk K, Hassan MS, Schwebke J, Vermund SH, Choudhury P. Prevalence of infectious diseases in Bangladeshi women living adjacent to a truck stand: HIV/STD/hepatitis/genital tract infections. Sex Transm Infect. 2001 Oct;77(5):344-50. doi: 10.1136/sti.77.5.344.
- Background: PubMed 9065140Goldenberg RL, Klebanoff MA, Nugent R, Krohn MA, Hillier S, Andrews WW. Bacterial colonization of the vagina during pregnancy in four ethnic groups. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1996 May;174(5):1618-21. doi: 10.1016/s0002-9378(96)70617-8.
- Background: PubMed 9284776Sewankambo N, Gray RH, Wawer MJ, Paxton L, McNaim D, Wabwire-Mangen F, Serwadda D, Li C, Kiwanuka N, Hillier SL, Rabe L, Gaydos CA, Quinn TC, Konde-Lule J. HIV-1 infection associated with abnormal vaginal flora morphology and bacterial vaginosis. Lancet. 1997 Aug 23;350(9077):546-50. doi: 10.1016/s0140-6736(97)01063-5.
- Background: PubMed 17197596Allsworth JE, Peipert JF. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstet Gynecol. 2007 Jan;109(1):114-20. doi: 10.1097/01.AOG.0000247627.84791.91.
- Background: PubMed 8124116Hay PE, Lamont RF, Taylor-Robinson D, Morgan DJ, Ison C, Pearson J. Abnormal bacterial colonisation of the genital tract and subsequent preterm delivery and late miscarriage. BMJ. 1994 Jan 29;308(6924):295-8. doi: 10.1136/bmj.308.6924.295.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig R Cohen, MD, MPH principal investigator
University of California, San Francisco
Anke Hemmerling, MD, MPH, PhD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LACTIN-V in people with Bacterial Vaginosis, run by Osel, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the vaginal colonization efficiency of L. crispatus CTV-05 after vaginal administration of LACTIN-V at 2 x 10^9 cfu/dose (600 mg) daily for 5 days followed by weekly applications over 2 additional weeks (time frame: 4 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00635622, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2009.