Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03151967
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2016-01-13
Brief Title:
Lactobacillus Probiotic for Prevention of UTI
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Lactobacillus Probiotic for Prevention of UTI
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 UTIs 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 UTIs 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 applicatorsThe 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 tamponinsert 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 UTIs 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
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 applicatorsThe 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 tamponinsert 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 UTIs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK088830-01A1 | NIH | None | httpsreporternihgovquickSearch1R01DK088830-01A1 |