RECRUITING

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

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Conditions

Recurrent UTIsRecurrent Urinary Tract InfectionsRecurrent Urinary Tract Infections in WomenRecurrent Urinary Tract InfectionCystitis RecurrentCystitis ChronicUTIUTI - Urinary Tract InfectionUTI - Lower Urinary Tract InfectionD-mannosedmannoserutiurinary tract infectioncystitischronic utichronic cystitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-01
Study Completion:2030-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06940622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 85 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female, post-menopausal, age ≥ 55 years old
  2. * Diagnosis of recurrent UTI, defined as ≥ 3 symptomatic culture-proven UTI episodes in 12 months or ≥ 2 in 6 months.
  3. * 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).
  4. * Able to attend all follow-up appointments for the study.
  5. * 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.
  1. * 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.
  2. * Complicated UTIs, including need for catheter drainage or intermittent catheterization, neurogenic bladder, bladder augmentation, or urinary diversion.
  3. * 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.
  4. * Evidence of upper tract infection (pyelonephritis), including temperature higher than 38°C, flank/lumbar pain or tenderness
  5. * Diagnosis of interstitial cystitis or overactive bladder syndrome
  6. * Prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start in the next 12 months
  7. * Use of Uromune or other vaccine approaches to reduce rUTI
  8. * Participation in a research study involving an investigational product in the past 12 weeks
  9. * Receipt of phage treatment
  10. * History of chronic diarrhea requiring regular therapy
  11. * Inability to swallow or known history of gastrointestinal malabsorption
  12. * History of recurrent vaginal yeast infections
  13. * 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).
  14. * Nursing home resident
  15. * BMI \>40
  16. * Multi-Vitamins and Multi-Mineral capsules
  17. * 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)
  18. * Probiotics
  19. * Cranberry Mannose or Cranberry Extract Weight loss products to avoid
  20. * Medifast
  21. * Vitafusion
  22. * OptiVin Products
  23. * Appetite Suppressants
  24. * Keto-Fuel

Contacts and Locations

Study Contact

Jessica de Araujo Paula
CONTACT
2146458787
jessica.dearaujopaula@utsouthwestern.edu
Meghan Leak
CONTACT
2146458787
meghan.leak@utsouthwestern.edu

Principal Investigator

Philippe Zimmern, MD
PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Philippe Zimmern, MD, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2030-09-30

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2030-09-30

Terms related to this study

Keywords Provided by Researchers

  • D-mannose
  • dmannose
  • uti
  • ruti
  • recurrent urinary tract infection
  • urinary tract infection
  • cystitis
  • chronic uti
  • chronic cystitis

Additional Relevant MeSH Terms

  • 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