Lactobacillus Crispatus for Urinary Tract Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat urinary tract infections (UTIs) in adults with neurogenic lower urinary tract dysfunction (NLUTD), often resulting from spinal cord injury (SCI), who use catheters. Researchers aim to determine if Lactobacillus crispatus, a type of bacteria, can safely alleviate urinary symptoms and reduce antibiotic use. Participants will receive either a bladder wash with this bacteria or saline (saltwater) to compare effects. Individuals who have had a spinal cord injury for at least six months, require a catheter for bladder issues, and live in the community may qualify for this trial. As an Early Phase 1 trial, this study focuses on understanding how this new treatment works in people, offering participants a chance to be among the first to receive it.
Will I have to stop taking my current medications?
The trial requires that you have not used oral or IV antibiotics in the past 2 weeks and that you are not using prophylactic antibiotics or intravesical antimicrobials to prevent UTIs. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that Lactobacillus crispatus is usually safe and well tolerated in people with certain urinary issues. In past studies, adults with neurogenic lower urinary tract dysfunction (NLUTD) safely used this probiotic, a type of "good" bacteria. This condition affects bladder function and often requires catheter use.
Participants in those studies did not report major side effects, suggesting the treatment might be safe. However, more research is needed to confirm these results. This trial is in its early stages, so more information is necessary to fully understand the treatment's safety in humans.12345Why do researchers think this study treatment might be promising?
Researchers are excited about using Lactobacillus Crispatus for urinary tract infections because it's a probiotic approach, which is quite different from the standard antibiotics usually prescribed. This treatment involves a unique delivery method where the probiotic is mixed with saline and directly instilled into the bladder. Unlike antibiotics that kill bacteria indiscriminately, Lactobacillus Crispatus aims to restore healthy bacterial balance, potentially reducing side effects and the risk of antibiotic resistance.
What evidence suggests that Lactobacillus crispatus might be an effective treatment for urinary tract infection?
Research shows that Lactobacillus crispatus, which participants in this trial may receive as a bladder wash, may help fight urinary tract infections (UTIs) by targeting harmful bacteria. In lab studies, L. crispatus significantly reduced Escherichia coli, the bacteria that often cause UTIs. Other research has found that probiotics like L. crispatus can help prevent recurrent UTIs. Additionally, using L. crispatus in different forms, such as vaginal suppositories, has been safe and has helped lower the number of UTIs. These findings suggest L. crispatus could be a promising non-antibiotic option for managing UTIs.46789
Who Is on the Research Team?
Suzanne Groah, MD
Principal Investigator
MedStar National Rehabilitation Hospital
Are You a Good Fit for This Trial?
This trial is for adults with neurogenic lower urinary tract dysfunction (NLUTD) due to spinal cord injury who use intermittent catheterization. It's not suitable for individuals without a clear diagnosis, those who don't use catheterization, or have conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravesical instillation of L. crispatus or saline solution and complete daily symptom surveys
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lactobacillus Crispatus
Trial Overview
The trial is testing if Lactobacillus Crispatus can be an alternative to antibiotics for UTI symptoms in NLUTD patients. Participants will receive bladder instillations of either this bacteria or saline and report their symptoms while providing urine samples.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subjects will draw up the 45cc sterile saline into a 60cc catheter tip syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Subjects will receive 2 doses of saline and will repeat this process the following night 24 hours (+/- 2 hours) apart.
L. crispatus mixed with normal saline and instilled into the bladder will be used for intervention group. Subjects in the intervention group will be instructed to mix the contents of the applicator (by depressing the plunger, which extrudes the L. crispatus powder) into 45 cc of sterile 0.9% saline. After mixing, subjects will draw up the 45cc liquid L. crispatus mixture into a 60cc catheter tip syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Subjects will receive 2 doses (each in separate applicators) of L.crispatus and will repeat this process the following night 24 hours (+/- 2 hours) apart.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medstar Health Research Institute
Lead Sponsor
Loyola University
Collaborator
Citations
Lactobacillus crispatus Limits Bladder Uropathogenic E. ...
Exposing infected human BECs to L. crispatus in vitro markedly reduced the intracellular uropathogenic Escherichia coli (UPEC) load.
Understanding the potential of lactobacilli in recurrent UTI ...
Probiotics appear to have a significant potential in prevention of recurrent UTI, however, additional data are needed to understand how they can be effectively ...
Evaluation of the effectiveness of probiotics in the treatment ...
The consequence of using probiotics in our study is clinically effective and laboratory investigation reveals pathogenic bacteria eradication.
Can vaginal lactobacillus suppositories help reduce urinary ...
Current data support the use of vaginal suppositories containing Lactobacillus as a safe, non-antibiotic measure, but actual reduction of rUTI in susceptible ...
Randomized, Placebo-Controlled Phase 2 Trial of a ...
Lactin-V after treatment for cystitis is associated with a reduction in recurrent UTI. Larger efficacy trials of this novel preventive method for recurrent UTI ...
6.
trial.medpath.com
trial.medpath.com/clinical-trial/fd5082d32a7af967/nct07308808-intravesical-lactobacillus-crispatus-safety-microbiomeIntravesical Lactobacillus Crispatus: Clinical Safety ... - MedPath
crispatus is safe and well tolerated in adults with NLUTD due to SCI who use intermittent catheterization (IC). If there is a comparison group: ...
Probiotics for preventing urinary tract infection in people with ...
This review looked at the benefits and harms of probiotics in preventing symptomatic UTI in people with neuropathic bladder compared with placebo, no therapy, ...
Recurrent Uncomplicated Urinary Tract Infections in Women
For studies on treatment and prevention of UTI, outcomes were UTI recurrence, UTI-related symptoms, recurrence rate, hospitalization, antimicrobial ...
The Impact of Self-Management with Probiotics on Urinary ...
evaluating the safety and effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infection.
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