Actively Recruiting

Phase Not Applicable
Age: 55Years - 85Years
FEMALE
NCT06940622

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

Led by University of Texas Southwestern Medical Center · Updated on 2025-09-22

90

Participants Needed

1

Research Sites

269 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 55Years - 85Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, post-menopausal, age 55 years or older
  • History of recurrent urinary tract infections with 3 or more symptomatic culture-proven episodes in 12 months or 2 or more in 6 months
  • Currently free from urinary tract infection symptoms and negative urine culture
  • Able to attend all follow-up appointments during the study
  • Negative upper and lower urinary tract evaluation including pelvic exam (prolapse less than stage 2), post-void residual less than 50 ml, and imaging to exclude kidney stones, hydronephrosis, reflux, or urethral diverticulum
Not Eligible

You will not qualify if you...

  • Current use of D-mannose (must stop and complete 4-week washout to join)
  • Complicated urinary tract infections requiring catheter use or with neurogenic bladder, bladder augmentation, or urinary diversion
  • Use of other supplements listed in Box 1 (must stop and complete 4-week washout to join)
  • Evidence of upper urinary tract infection such as fever over 38°C or flank pain
  • Diagnosis of interstitial cystitis or overactive bladder syndrome
  • Use of prophylactic antibiotics started in last 3 months and unwilling to stop, or intention to start in next 12 months
  • Use of Uromune or other vaccines for recurrent UTI
  • Participation in other investigational product studies in past 12 weeks
  • Receipt of phage treatment
  • History of chronic diarrhea requiring regular treatment
  • Inability to swallow or gastrointestinal malabsorption
  • History of recurrent vaginal yeast infections
  • Systemic diseases preventing enrollment including uncontrolled diabetes (HgA1C above 7), ongoing chemotherapy or immunotherapy, renal insufficiency (creatinine > 1.5 g/dl), cognitive impairment, or restrictive diets requiring large fluid intake
  • Nursing home residents
  • Body mass index over 40

Box 1 Supplements to avoid:

  • Multi-vitamins and multi-mineral capsules
  • Specific vitamins or minerals (e.g., calcium, vitamin A, D, niacin, selenium, vitamin E, iron, omega 3, magnesium, B-complex)
  • Probiotics
  • Cranberry mannose or cranberry extract
  • Weight loss products like Medifast, Vitafusion, OptiVin, appetite suppressants, Keto-Fuel

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

J

Jessica de Araujo Paula

CONTACT

M

Meghan Leak

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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