D-mannose for Urinary Tract Infection

(DmannoseRCT Trial)

Overseen By Jessica de Araujo Paula

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Prophylactic antibiotics, Uromune

Disqualifiers: Complicated UTIs, Interstitial cystitis, Diabetes, Chemotherapy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires you to stop taking D-mannose and certain supplements, with a 4-week period without them before joining. If you're on prophylactic antibiotics, you must be willing to stop them to participate.

What data supports the effectiveness of the treatment D-mannose for urinary tract infections?

Research suggests that D-mannose, a type of sugar, can help prevent bacteria from sticking to the bladder walls, which may reduce urinary tract infections (UTIs). Some studies have shown that D-mannose can be as effective as antibiotics in treating acute UTIs in women, making it a promising alternative. ^{1 2 3 4 5}

Is D-mannose safe for humans?

D-mannose is a sugar naturally found in many foods and is part of normal human metabolism. Early studies in both animals and humans have used D-mannose in doses ranging from 200 mg to 3 g, and while they focus on its effectiveness, they do not report significant safety concerns. ^{2 3 4 6 7}

How does the treatment D-mannose differ from other treatments for urinary tract infections?

D-mannose is unique because it is a sugar that prevents bacteria from sticking to the walls of the urinary tract, helping to flush them out through urination. Unlike antibiotics, it is a nonantibiotic option that may reduce the frequency of recurrent urinary tract infections, especially in women with certain conditions like cystitis cystica. ^{1 2 3 4 7}

What is the purpose of this trial?

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.

Research Team

Philippe Zimmern, MD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

This trial is for post-menopausal women aged 55 or older who have had at least 3 UTIs in the past year. They must be currently free from a UTI, with no major urinary tract issues and able to attend all study visits. Women with very high BMI, recent investigational drug use, chronic health conditions like uncontrolled diabetes, or those on certain treatments are excluded.

Inclusion Criteria

I can attend all required follow-up appointments.

I am a woman over 55 and have gone through menopause.

I have had 3 or more UTIs in the last year or 2 in the last 6 months.

Exclusion Criteria

Participation in a research study involving an investigational product in the past 12 weeks

History of recurrent vaginal yeast infections

BMI >40

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive D-mannose or placebo daily for 12 months to test its effectiveness in preventing recurrent UTIs

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• D-Mannose

Trial Overview The study tests if D-mannose (2g daily) can prevent recurrent UTIs over a year compared to a placebo. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real treatment versus the placebo until after the results are collected.

Participant Groups

Group I: D-mannose Active Control 1 Intervention

Dietary Supplement: D-Mannose

Group II: Placebo Placebo Group 1 Intervention

Dietary Supplement: Placebo

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

References

1. Italy pubmed.ncbi.nlm.nih.gov

D-mannose: a promising support for acute urinary tract infections in women. A pilot study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

D-mannose for preventing and treating urinary tract infections. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Enzymatic assay of D-mannose from urine. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

d-mannosuria levels measured 1 h after d-mannose intake can select out favorable responders: A pilot study. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Why d-Mannose May Be as Efficient as Antibiotics in the Treatment of Acute Uncomplicated Lower Urinary Tract Infections-Preliminary Considerations and Conclusions from a Non-Interventional Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

D-mannose vs other agents for recurrent urinary tract infection prevention in adult women: a systematic review and meta-analysis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Recurrent Urinary Tract Infection Incidence Rates Decrease in Women With Cystitis Cystica After Treatment With d-Mannose: A Cohort Study. [2023]