Lactobacillus Probiotic for Prevention of UTI
Lactobacillus Probiotic for Prevention of UTI
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).
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.
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