Status:
RECRUITING
A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Recurrent UTIs
Recurrent Urinary Tract Infections
Eligibility:
FEMALE
55-85 years
Phase:
NA
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-men...
Detailed Description
The proposed study on D-mannose prophylaxis is designed to address a critical unmet medical need to improve the understanding and prevention of rUTI (recurrent urinary tract infection) in post-menopau...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06940622
Start Date
August 1 2025
End Date
September 30 2030
Last Update
September 22 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390