Urinary Tract Infections (UTI's)Phase 2/3NCT03151967
Lactobacillus Probiotic for Prevention of UTI
A Phase 2/3 study testing Lactobacillus crispatus CTV-05 in people with Urinary Tract Infections (UTI's), run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Urinary Tract Infections (UTI's)
- What is being tested?
- Lactobacillus crispatus CTV-05
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to 5 Apr 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hall Health Primary Care Center
Seattle, Washington, 98115
University of Washington
Seattle, Washington, 98195
About this study
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).
Read the 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.
- Conditions
- Urinary Tract Infections (UTI's)
- Being tested
- Lactobacillus crispatus CTV-05, Placebo
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus crispatus CTV-05Drug
Also called Lactin-V
vaginal applicator with medium containing drug
PlaceboDrug
vaginal applicator with medium containing no drug
| Study group | Role | What they receive |
|---|---|---|
| Applicator with LACTIN-V Treatment | Active comparator | Vaginal applicator containing Lactobacillus crispatus CTV-05 Receives: Drug: Lactobacillus crispatus CTV-05 |
| Applicator with Placebo | Placebo comparator | Inactive vaginal applicator without any drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 2-18
Secondary outcomes (1)
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
Measured: Weeks 0, 2, 6, 10, 14 and18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study startSep 2015
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract Infections (UTI's)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Stapleton, University of Washington
- Investigators
- Ann E Stapleton, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151967
- Sponsor's protocol ID
- STUDY00000160
- Other IDs
- 1R01DK088830-01A1
- Status last verified
- Feb 2023
- First submitted
- 13 Jan 2016
- Last updated
- 1 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Probiotic for Prevention of UTI
- ClinicalTrials.gov ID
- NCT03151967
- Acronym / sponsor ID
- STUDY00000160
- Conditions
- Urinary Tract Infections (UTI's)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2015 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Applicator with LACTIN-V Treatment | Active comparator | Drug: Lactobacillus crispatus CTV-05Vaginal applicator containing Lactobacillus crispatus CTV-05 |
| Applicator with Placebo | Placebo comparator | Drug: PlaceboInactive vaginal applicator without any drug |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Lactobacillus crispatus CTV-05Also: Lactin-Vvaginal applicator with medium containing drug | Drug | Applicator with LACTIN-V Treatment |
| Placebovaginal applicator with medium containing no drug | Drug | Applicator with Placebo |
Primary outcome
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).
Time frame: 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
1 secondary outcome
Parameter of Vaginal Colonization
Time frame: Weeks 0, 2, 6, 10, 14 and18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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UTI's
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.
Ann E Stapleton, MD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lactobacillus crispatus CTV-05 in people with Urinary Tract Infections (UTI's), run by University of Washington at 2 sites 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 6 inclusion and 14 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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). (time frame: Week 2-18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2023.