NCT06940622

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	D-Mannose	D-mannose (2g, i.e., 4 x 500mg capsules) daily for 12 months.
DIETARY_SUPPLEMENT	Placebo	Placebo daily for 12 months.

Timeline

• Start date: 2025-08-01
• Primary completion: 2029-09-30
• Completion: 2030-09-30
• First posted: 2025-04-23
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States