Lactobacillus Probiotic for Prevention of UTI
Condition: Urinary Tract Infections (UTI's)
MeSH terms: Urinary Tract Infections
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Lactobacillus crispatus CTV-05; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): vaginal applicator with medium containing drug; vaginal applicator with medium containing no drug
Other intervention name(s): Lactin-V
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention