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NCT06940622 | RECRUITING | Recurrent UTIs

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

University of Texas Southwestern Medical Center

Information provided by (Responsible Party):

Philippe Zimmern

Brief 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.

Condition or disease

Recurrent UTIs

Recurrent Urinary Tract Infections

Recurrent Urinary Tract Infections in Women

Recurrent Urinary Tract Infection

Cystitis Recurrent

Cystitis Chronic

UTI

UTI - Urinary Tract Infection

UTI - Lower Urinary Tract Infection

Intervention/treatment

D-Mannose

Placebo

Phase

NA

Detailed Description:

The proposed study on D-mannose prophylaxis is designed to address a critical unmet medical need to improve the understanding and prevention of rUTI (recurrent urinary tract infection) in post-menopausal women, a population disproportionately affected by rUTI and understudied. The efficacy of D-mannose on preventing uncomplicated rUTI will be elucidated, and additional study measures (including urine culture and one-hour D-mannose test results) may help establish an ideal candidate for responding to daily D-mannose intake over time. The proposed study will follow CONSORT guidelines for randomized clinical trial studies. Aim 1. Test the hypothesis that D-mannose provides effective rUTI prophylaxis in post-menopausal women over 6 months. Aim 2. Test the hypothesis that D-mannose provides effective rUTI prophylaxis in post-menopausal women beyond 6 months and up to one year. The overarching hypotheses are that (1) D-mannose will be found superior to placebo in preventing rUTI in post-menopausal women over 6 months as suggested by one prior RCT7 (Aim 1) and (2) D-mannose will remain effective for rUTI prophylaxis up to one year (Aim 2). Ninety (90) women currently UTI-free and with a history of uncomplicated rUTI, defined as ≥ 2 symptomatic UTIs in 6 months or ≥ 3 symptomatic UTIs in 12 months, will be enrolled and randomized (2:1 ratio) to receive D-mannose (2g, i.e., 4 x 500mg capsules) or placebo daily for 12 months.

Study Type : INTERVENTIONAL
Estimated Enrollment : 90 participants
Masking : QUADRUPLE
Primary Purpose : PREVENTION
Official Title : A Randomized Controlled Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections in Post-menopausal Women
Actual Study Start Date : 2025-08-01
Estimated Primary Completion Date : 2029-09-30
Estimated Study Completion Date : 2030-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 55 Years to 85 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections

Location Details

NCT06940622

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Locations

RECRUITING

United States, Texas

University of Texas Southwestern Medical Center

dallas, Texas, United States, 75390