NCT06940622 A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections
| NCT ID | NCT06940622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Recurrent UTIs |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2029-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-08-01 with a primary completion date of 2029-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A randomized, double-blind, placebo-controlled, 12-month study to determine the effectiveness of D-mannose (2g daily) supplementation in rUTI (recurrent urinary tract infection) prevention in post-menopausal women.
Eligibility Criteria
Inclusion Criteria: * Female, post-menopausal, age ≥ 55 years old * Diagnosis of recurrent UTI, defined as ≥ 3 symptomatic culture-proven UTI episodes in 12 months or ≥ 2 in 6 months. * Currently free from a UTI determined based on absence of symptoms as determined by the UTI symptom assessment questionnaire79 and negative urine culture (\<103 colony forming units per ml of urine). * Able to attend all follow-up appointments for the study. * A negative upper and lower urinary tract evaluation, including pelvic examination for pelvic organ prolapse (less than stage 2), measurement of post-void residual (less than 50 ml), and imaging (renal ultrasound and standing voiding cystourethrogram) to exclude kidney stone, hydronephrosis, reflux, or urethral diverticulum. Exclusion Criteria: * Current use of D-mannose. Patients willing to stop taking D-mannose will be offered to join the trial after a 4-week wash-out period. * Complicated UTIs, including need for catheter drainage or intermittent catheterization, neurogenic bladder, bladder augmentation, or urinary diversion. * Ongoing supplement use (Box 1). Patients willing to stop taking the listed supplements will be offered to join the trial after a 4-week wash-out period. * Evidence of upper tract infection (pyelonephritis), including temperature higher than 38°C, flank/lumbar pain or tenderness * Diagnosis of interstitial cystitis or overactive bladder syndrome * Prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start in the next 12 months * Use of Uromune or other vaccine approaches to reduce rUTI * Participation in a research study involving an investigational product in the past 12 weeks * Receipt of phage treatment * History of chronic diarrhea requiring regular therapy * Inability to swallow or known history of gastrointestinal malabsorption * History of recurrent vaginal yeast infections * Systemic disease precluding enrollment in this study (uncontrolled diabetes with HgA1C above 7, ongoing chemotherapy or immunotherapy, renal insufficiency \[creatinine \> 1.5 g/dl\]), mental or cognitive impairment, weight loss diet requiring excessively large amounts of fluid intake, or other health-related specific diet). * Nursing home resident * BMI \>40 Box 1 Supplements to avoid * Multi-Vitamins and Multi-Mineral capsules * Specific Vitamins or Minerals (e.g., Calcium, Citrical, Calcium Gummies, Vitamin A, D, Niacin, Pyridoxine, Selenium, Vitamin E, B6, Iron, Omega 3, D3, Magnesium, B-Complex, Women's Ultra MultiVitamin, GNC B-Complex, B-12, PreserVision Areds2, Vitamins D, B Pollen) * Probiotics * Cranberry Mannose or Cranberry Extract Weight loss products to avoid * Medifast * Vitafusion * OptiVin Products * Appetite Suppressants * Keto-Fuel
Contact & Investigator
Philippe Zimmern, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06940622 clinical trial?
This trial is open to female participants only, aged 55 Years or older, up to 85 Years, studying Recurrent UTIs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06940622 currently recruiting?
Yes, NCT06940622 is actively recruiting participants. Contact the research team at jessica.dearaujopaula@utsouthwestern.edu for enrollment information.
Where is the NCT06940622 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06940622 clinical trial?
NCT06940622 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Philippe Zimmern, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 90 participants.