Actively Recruiting
Randomized Trial of D-mannose for Preventing Recurrent Urinary Tract Infections in Post-menopausal Women
Led by University of Texas Southwestern Medical Center · Updated on 2025-09-22
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of D-mannose supplementation to prevent recurrent urinary tract infections (rUTI) in post-menopausal women. This randomized, double-blind, placebo-controlled study aims to improve understanding of rUTI prevention in this population, which is disproportionately affected and understudied. The study tests whether daily D-mannose intake over 6 months and up to one year effectively reduces the occurrence of uncomplicated rUTIs compared to placebo. Participants will be randomly assigned in a 2:1 ratio to receive either D-mannose (2 grams daily, taken as four 500 mg capsules) or a placebo for 12 months. The study follows CONSORT guidelines and includes two groups: one receiving the active supplement and the other receiving a placebo. The study aims to enroll 90 women who are currently free of UTI but have a history of recurrent infections. During the study, participants will attend follow-up appointments to monitor urinary tract health through urine cultures and symptom assessments. Researchers will collect data on failure rates, number of antibiotic treatments for UTI, symptom severity, and any serious adverse events related to D-mannose over an average follow-up of five years. This allows long-term observation of the supplement's impact on rUTI prevention and safety.
CONDITIONS
Brief 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
- Diagnosed with recurrent urinary tract infections, defined as 3 or more symptomatic culture-proven UTI episodes in 12 months or 2 or more in 6 months
- Currently free from urinary tract infection based on symptom assessment and negative urine culture
- Able to attend all scheduled follow-up appointments
- Negative urinary tract evaluation including pelvic exam, post-void residual less than 50 ml, and imaging showing no kidney stones or other abnormalities
You will not qualify if you...
- Current use of D-mannose without a 4-week wash-out period
- Complicated urinary tract infections requiring catheter drainage or with neurogenic bladder
- Use of certain supplements without a 4-week wash-out period
- Evidence of upper urinary tract infection such as fever or flank pain
- Diagnosis of interstitial cystitis or overactive bladder syndrome
- Recent or planned use of prophylactic antibiotics or vaccines for rUTI
- Participation in other investigational research within 12 weeks
- Receipt of phage treatment
- Chronic diarrhea requiring regular therapy
- Inability to swallow or gastrointestinal malabsorption
- History of recurrent vaginal yeast infections
- Serious systemic diseases or conditions like uncontrolled diabetes, ongoing chemotherapy, or renal insufficiency
- Nursing home residency
- Body mass index over 40
- Use of specific vitamins, minerals, probiotics, cranberry products, or weight loss supplements listed in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants take D-mannose or placebo daily to prevent recurrent urinary tract infections.
Regular visits for monitoring and assessments during the 12 months of daily supplementation
Duration - Up to 4 years after treatment completion
Participants are monitored for outcomes related to urinary tract infections and safety after completing the treatment period.
Visits as scheduled for long-term monitoring up to study completion
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
M
Meghan Leak
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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