Actively Recruiting
A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections
Led by University of Texas Southwestern Medical Center · Updated on 2025-09-22
90
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, post-menopausal, age 55 years or older
- History of recurrent urinary tract infections with 3 or more symptomatic culture-proven episodes in 12 months or 2 or more in 6 months
- Currently free from urinary tract infection symptoms and negative urine culture
- Able to attend all follow-up appointments during the study
- Negative upper and lower urinary tract evaluation including pelvic exam (prolapse less than stage 2), post-void residual less than 50 ml, and imaging to exclude kidney stones, hydronephrosis, reflux, or urethral diverticulum
You will not qualify if you...
- Current use of D-mannose (must stop and complete 4-week washout to join)
- Complicated urinary tract infections requiring catheter use or with neurogenic bladder, bladder augmentation, or urinary diversion
- Use of other supplements listed in Box 1 (must stop and complete 4-week washout to join)
- Evidence of upper urinary tract infection such as fever over 38°C or flank pain
- Diagnosis of interstitial cystitis or overactive bladder syndrome
- Use of prophylactic antibiotics started in last 3 months and unwilling to stop, or intention to start in next 12 months
- Use of Uromune or other vaccines for recurrent UTI
- Participation in other investigational product studies in past 12 weeks
- Receipt of phage treatment
- History of chronic diarrhea requiring regular treatment
- Inability to swallow or gastrointestinal malabsorption
- History of recurrent vaginal yeast infections
- Systemic diseases preventing enrollment including uncontrolled diabetes (HgA1C above 7), ongoing chemotherapy or immunotherapy, renal insufficiency (creatinine > 1.5 g/dl), cognitive impairment, or restrictive diets requiring large fluid intake
- Nursing home residents
- Body mass index over 40
Box 1 Supplements to avoid:
- Multi-vitamins and multi-mineral capsules
- Specific vitamins or minerals (e.g., calcium, vitamin A, D, niacin, selenium, vitamin E, iron, omega 3, magnesium, B-complex)
- Probiotics
- Cranberry mannose or cranberry extract
- Weight loss products like Medifast, Vitafusion, OptiVin, appetite suppressants, Keto-Fuel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
J
Jessica de Araujo Paula
CONTACT
M
Meghan Leak
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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