Nutritional Supplementation for Recurrent Urinary Tract Infections in Women (NCT03597152) | Clinical Trial Compass
UnknownNot Applicable
Nutritional Supplementation for Recurrent Urinary Tract Infections in Women
250 participantsStarted 2020-08-01
Plain-language summary
The study will test the ability of specially formulated nutritional supplement capsules to extend the time between recurrent urinary tract infections in women. This objective will be completed by enrolling women who have suffered from 3-4 uncomplicated UTIs in the past 12 months into a double blind placebo controlled cross-over trial. Cross-over and study completion are triggered by the next two UTI recurrences. The goal of the study is for the supplement to extend the time to the next UTI for study participants as compared to placebo.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
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:
* Presenting with symptoms of UTI
* Presentation of 3rd or 4th simple cystitis of lower tract in the past 12 months
* Active infection at enrollment, confirmed and documented in medical record
* Cognitive capacity to consent and ability to undergo the consent process in English
Exclusion Criteria:
* Known allergy or intolerance to supplement ingredients
* Pregnant or planning to become pregnant or lactating
* Unwilling to commit to birth control use
* Use of related nutritional supplements
* Unwilling to halt berry extracts, polyphenols, antioxidants, d-mannose, vitamins
* Taken WelTract in past six months
* Unwilling to avoid probiotics, yogurt, apple or cranberry juice, hibiscus tea
* Certain comorbid or physical conditions
* History of febrile UTI
* Bladder catheter or urethral stents
* Use of topical hormones in urogenital areas
* Diabetes (i.e. taking diabetic medications) or glycosuria
* Intestinal diseases with malabsorption (e.g. Crohn's and celiac diseases)
* Severe renal impairment or kidney stones
* Neural problems (spinal cord injury or Multiple Sclerosis)
* Immunocompromised individuals
* Rheumatoid arthritis
* Lupus
* HIV
* Taking steroids or immunobiologic medications
* Prophylactic antibiotic use (e.g. post-coital)
* Other physician judgement
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
UTI Recurrence
Timeframe: Variable for each participant over course of up to one year