A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Urinary Tract Infect… (NCT04100980) | Clinical Trial Compass
WithdrawnNot Applicable
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Urinary Tract Infections (UTI)
Stopped: Company shifted focus
United States0Started 2020-03-02
Plain-language summary
Correlation of Microbiome to Chronic Urinary Tract Infections (UTI) via Relative Abundance Found in Microbiome Sequencing
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent by patient
. Male or female patients age 18 and older.
. Diagnosis of chronic UTIs by a physician based upon urinalysis and/or urine culture.
Exclusion criteria
. Refusal by patient to sign informed consent form
. Treatment with antibiotics within 2 weeks prior to screening
. Treatment with probiotics within 6 weeks prior to screening
. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
. Postoperative stoma, ostomy, or ileoanal pouch
. Participation in any experimental drug protocol within the past 12 weeks
. Treatment with total parenteral nutrition
. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1I found a study called NCT04100980 that was looking at the connection between gut bacteria and chronic UTIs — my records show it was withdrawn before enrolling anyone, so is there any way to find out why it was withdrawn and whether a similar or updated study is now available?
2Since this was a non-interventional, observational study focused on microbiome sequencing rather than a new treatment, are there other research programs currently recruiting chronic UTI patients that take a similar approach to understanding the gut-bladder connection?
3Given that this study was exploring the microbiome's role in chronic UTIs, is microbiome testing something you could order for me now outside of a clinical trial, and would the results actually change how you manage my treatment?
4Because this trial never got off the ground, what does the current evidence say about the relationship between gut flora and chronic UTIs, and should that influence any dietary or probiotic choices I'm making right now?
5Are there any active clinical trials for chronic UTI that you'd recommend I look into instead, particularly ones that might offer new diagnostic tools or treatments beyond the standard antibiotic approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of Microbiome to chronic Urinary Tract Infection (UTI) via Relative Abundance Found in Microbiome Sequencing