A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a daily supplement called D-mannose can help prevent recurrent urinary tract infections (UTIs) in post-menopausal women. Recurrent UTIs are defined as having three or more infections in a year or two in six months. The trial aims to see if taking 2 grams of D-mannose daily for 12 months can reduce the chances of getting these infections again.

To participate, women must be at least 55 years old, have a history of recurrent UTIs, and be currently free of any UTI symptoms. They also need to be able to attend all follow-up appointments. Participants will not be allowed to use certain supplements or medications during the study, and they will be monitored closely to ensure their health is stable throughout the trial. This study is not yet recruiting, but it represents an opportunity to explore a potential new way to manage a common and uncomfortable health issue.

Gender

FEMALE

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