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

NCT06940622 | Recruiting

• 1 other identifier: STU-2024-1090
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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; Cystitis Chronic; UTI; UTI - Urinary Tract Infection; UTI - Lower Urinary Tract Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Failure rate

  To determine whether prophylaxis with D-mannose reduces the incidence of UTI episodes compared to placebo. "Failure rate," defined as having 2 UTIs in 6 months or 3 in one year.

  Through study completion, an average of 5 years

Secondary Outcomes (3)

• Number of UTI antibiotic treatments

  Through study completion, an average of 5 years

• Symptom severity

  Through study completion, an average of 5 years

• Serious adverse events associated with D-mannose

  Through study completion, an average of 5 years

Study Arms (2)

D-mannose

ACTIVE COMPARATOR

Dietary Supplement: D-Mannose

Dietary Supplement: D-Mannose

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Dietary Supplement: Placebo

Interventions

D-Mannose DIETARY_SUPPLEMENT

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

D-mannose

Placebo DIETARY_SUPPLEMENT

Placebo daily for 12 months.

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections; Cystitis

Interventions

Mannose

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Philippe Zimmern, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica de Araujo Paula

CONTACT

2146458787; jessica.dearaujopaula@utsouthwestern.edu

Meghan Leak

CONTACT

2146458787; meghan.leak@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: D-mannose and placebo

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 23, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2030
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)