Recruiting

D-Mannose

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06940622

Conditions

Recurrent UTIs

Recurrent Urinary Tract Infections

Recurrent Urinary Tract Infections in Women

Recurrent Urinary Tract Infection

Cystitis Recurrent

Eligibility Criteria

Sex: Female

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

D-Mannose

Placebo

Study Details

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.

Conditions

Recurrent UTIs

Recurrent Urinary Tract Infections

Recurrent Urinary Tract Infections in Women

Recurrent Urinary Tract Infection

Cystitis Recurrent

Study ID

NCT06940622

Start date

Aug 1, 2025

Status verified date

Sep, 2025

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: D-mannose

Dietary Supplement: D-Mannose

placebo comparator: Placebo

Dietary Supplement: Placebo

Interventions

D-Mannose

D-mannose (2g, i.e., 4 x 500mg capsules) daily for 12 months.

Placebo

Placebo daily for 12 months.

Primary outcome measure

  • Failure rate [ Time Frame: Through study completion, an average of 5 years ]

Central Contacts and Locations

Central contacts

Jessica de Araujo Paula

2146458787jessica.dearaujopaula@utsouthwestern.edu

Meghan Leak

2146458787meghan.leak@utsouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Sonobia Garrett, BSHS

214-645-8787sonobia.garrett@utsouthwestern.edu

philippe.zimmern@utsouthwestern.edu

Principal Investigator:

Philippe E Zimmern, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-09-22.