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New treatment option for Recurrent UTIs
Official title A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections
ClinicalTrials.gov ID: NCT06940622
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 85, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
- 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
See the full eligibility 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...
- 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...
- 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...
- Probiotics
- Cranberry Mannose or Cranberry Extract Weight loss products to avoid
- Medifast
- Vitafusion
- OptiVin Products
- Appetite Suppressants
- Keto-Fuel
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 55 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.