Urinary Tract Infections (UTI's)
Conditions
Brief summary
The purpose of this research is to see whether LACTIN-V (Lactobacillus crispatus CTV-05) is an effective method of preventing recurrent urinary tract infections (UTI's) and to learn the side effects of LACTIN-V. LACTIN-V is a vaginal applicator that contains Lactobacillus crispatus, an organism found naturally in the vaginas of healthy women. Lactobacillus bacteria are thought to help prevent other bacteria such as E. coli from causing UTI's. This is a double blind study comparing active product to a placebo (inactive vaginal applicator without any medicine).
Detailed description
The initial study visit will take about one hour. Participants will read, discuss and sign a consent form. Investigators will have the patient collect a mid-stream urine sample which will be sent to the research lab to confirm the participant has a urinary tract infection (UTI). Participants will than be given Macrobid twice a day for five days for UTI treatment. If the results of the screening show eligibility for this study, investigators will ask the participant to return to the clinic within 3-10 day after completing UTI treatment for a randomization visit (v1). Visit 1 (Randomization Visit): During this visit, the participant will be asked about any urinary or vaginal symptoms. The participant will be asked to provide a urine sample to see if the UTI has resolved and for a pregnancy test. The participant will have a physical exam including a pelvic and speculum exam. A study nurse practitioner will collect vaginal specimens to test for vaginal bacteria and vaginal infections. Next, the participant will be randomly assigned (like flipping a coin) to use LACTIN-V or placebo vaginal applicators. The participant will not be told which product is being used, and the researchers will not know until the end of the study. The participant will not be able to tell which one is being used. Each LACTIN-V applicator contains Lactobacillus crispatus CTV-O5 and other preservatives. Each placebo suppository contains other preservatives. Participants will be instructed how to use the applicators. The participant will also be given written instructions on how to use, store, and handle the applicators, and a diary to record when the participant uses the applicators and any symptoms that may happen during the study. (Participants will be given 15 applicators).The participant will insert 15 applicators during this study. The applicators are to be used daily for five days during the first week and then once per week for 10 weeks starting the second week. To insert an applicator, the participant will hold one applicator between a thumb and finger (like a tampon),insert the applicator into the opening of the vagina, and then push the applicator plunger. The participant will insert the first applicator in the clinic during this visit. The participant will be asked not to have sexual intercourse or use tampons for 24 hours after inserting an applicator. The participant will also be asked not to use spermicidal vaginal products. The participant will also be asked not to use other vaginal products such as creams, gels, foams, sponges, lubricants, or douches or take antibiotics for a UTI during this study unless the participants doctor prescribes it. The visit will take 30-60 minutes. Visits 2-6 The participant will then be asked to return to the Hall Health clinic in 2 weeks and then once a month for the next 4 months, after the randomization visit. During these visits a study nurse practitioner will ask about any side-effects that may have occurred from the study drug or placebo. The study nurse practitioner will also ask if the participant had any UTI's since the last visit. The participant will be asked to give a urine sample for culture. The participant will also have a physical exam, and vaginal tests for infection, lactobacillus (including lactobacillus from LACTIN-V) and E. coli. A speculum exam will only be done at v1 and the last visit unless the participant has symptoms of a vaginal infection. The last visit will include a urine pregnancy test. These visits will take 30 minutes. Other Visits: If the participant has a UTI or vaginal infection during the study, the participant will be seen at Hall Health for treatment. The participant will be treated with a standard medication at no cost.. If a UTI occurs during the study the participant will continue to use the study applicator on schedule.
Interventions
vaginal applicator with medium containing drug
DRUGPlacebo
vaginal applicator with medium containing no drug
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* pre-menopausal women * present with an acute, uncomplicated, culture confirmed UTI, defined as dysuria, urgency and/or frequency * at least one previous medically diagnosed UTI in past 12 months * using a reliable method of birth control ie: history of tubal ligation, male partner with vasectomy, steroidal contraception, Nuva-Ring, IUD, use of non spermicidal condoms or abstinence. * can provide written consent * can understand and read English
Exclusion criteria
* history of urogenital infection within the past 30 days, including: UTI, medically diagnosed vaginitis * current symptoms suggestive of pyelonephritis (fever\>100.4, flank pain of costovertebral angle tenderness, nausea and vomiting * history of functional or anatomic urologic abnormalities, urologic surgery of chronic urinary catheterization * history of pyelonephritis within the past 6 months * diagnosis of N. gonorrhoeae, C. trachomatis or T. vaginalis on two or more occasions during previous six months * known HIV infection of seropositivity * investigational drug use within 30 days of enrollment visit or current participation in another clinical trial * diabetes, other significant medical problem or intercurrent acute illness that in the Nurse Practitioner's and/or Principal 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 objective. At the randomization visit, has any of the following findings on pelvic or other physical examination: * unable to visualize cervix * clinically significant abnormalities, such as inflammation, erosion and/or petechiae (bleeding under the skin) of external genitalia, vaginal or cervix on visual examination * clinically significant tenderness on bimanual examination during the pelvic examination * evidence of vaginitis or a sexually-transmitted disease * any diagnosis requiring antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UTI Incidence as Described Below, Over the 16 Week Study Period Following Randomization, in the LACTIN-V Treatment Group (Group A) as Compared to the Placebo Group (Group B). | Week 2-18 | Symptomatic UTI : Comparison of the number (%) of subjects over the 16-week study period following randomization, with at least one symptomatic UTI (as defined above) in the 2 intervention groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parameter of Vaginal Colonization | Weeks 0, 2, 6, 10, 14 and18 | Lactobacillus crispatus positive (as assessed by repPCR) at Weeks 0,2,6,10,14, and 18 in the Lactin-V group as compared to the placebo group |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Applicator With LACTIN-V Treatment Vaginal applicator containing Lactobacillus crispatus CTV-05
Lactobacillus crispatus CTV-05: vaginal applicator with medium containing drug | 14 |
| Applicator With Placebo Inactive vaginal applicator without any drug
Placebo: vaginal applicator with medium containing no drug | 13 |
| Total | 27 |
Baseline characteristics
| Characteristic | Applicator With LACTIN-V Treatment | Applicator With Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 13 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 12 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants | 16 Participants |
| Region of Enrollment United States | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 14 / 14 | 13 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
UTI Incidence as Described Below, Over the 16 Week Study Period Following Randomization, in the LACTIN-V Treatment Group (Group A) as Compared to the Placebo Group (Group B).
Symptomatic UTI : Comparison of the number (%) of subjects over the 16-week study period following randomization, with at least one symptomatic UTI (as defined above) in the 2 intervention groups
Time frame: Week 2-18
Population: completed follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Applicator With LACTIN-V Treatment | UTI Incidence as Described Below, Over the 16 Week Study Period Following Randomization, in the LACTIN-V Treatment Group (Group A) as Compared to the Placebo Group (Group B). | 7 Participants |
| Applicator With Placebo | UTI Incidence as Described Below, Over the 16 Week Study Period Following Randomization, in the LACTIN-V Treatment Group (Group A) as Compared to the Placebo Group (Group B). | 7 Participants |
Secondary
Parameter of Vaginal Colonization
Lactobacillus crispatus positive (as assessed by repPCR) at Weeks 0,2,6,10,14, and 18 in the Lactin-V group as compared to the placebo group
Time frame: Weeks 0, 2, 6, 10, 14 and18
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Applicator With LACTIN-V Treatment | Parameter of Vaginal Colonization | Week 0 | 0 Number of Participants with Lactobac |
| Applicator With LACTIN-V Treatment | Parameter of Vaginal Colonization | Week 2 | 7 Number of Participants with Lactobac |
| Applicator With LACTIN-V Treatment | Parameter of Vaginal Colonization | Week 6 | 8 Number of Participants with Lactobac |
| Applicator With LACTIN-V Treatment | Parameter of Vaginal Colonization | Week 10 | 9 Number of Participants with Lactobac |
| Applicator With LACTIN-V Treatment | Parameter of Vaginal Colonization | Week 14 | 9 Number of Participants with Lactobac |
| Applicator With LACTIN-V Treatment | Parameter of Vaginal Colonization | Week 18 | 7 Number of Participants with Lactobac |
| Applicator With Placebo | Parameter of Vaginal Colonization | Week 14 | 0 Number of Participants with Lactobac |
| Applicator With Placebo | Parameter of Vaginal Colonization | Week 0 | 0 Number of Participants with Lactobac |
| Applicator With Placebo | Parameter of Vaginal Colonization | Week 10 | 0 Number of Participants with Lactobac |
| Applicator With Placebo | Parameter of Vaginal Colonization | Week 2 | 0 Number of Participants with Lactobac |
| Applicator With Placebo | Parameter of Vaginal Colonization | Week 18 | 0 Number of Participants with Lactobac |
| Applicator With Placebo | Parameter of Vaginal Colonization | Week 6 | 0 Number of Participants with Lactobac |