RecruitingNot ApplicableNCT06940622

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

A Randomized Controlled Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections in Post-menopausal Women

Sponsor

University of Texas Southwestern Medical Center

Enrollment

90 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Recurrent Urinary Tract Infections Recurrent UTIs Recurrent Urinary Tract Infections in Women

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-menopausal women.

Eligibility

Sex: FEMALEMin Age: 55 YearsMax Age: 85 Years

Inclusion Criteria5

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 Criteria25

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