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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether D-mannose, a type of sugar, can prevent recurring urinary tract infections (UTIs) in post-menopausal women. Participants will receive either D-mannose or a placebo (a harmless pill with no active ingredient) to determine if D-mannose makes a difference. It suits women who have experienced at least three UTIs in the past year but are currently symptom-free. As an unphased trial, this study provides a unique opportunity to contribute to research that may enhance future UTI prevention strategies.

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.

Is there any evidence suggesting that D-mannose is likely to be safe for humans?

Research has shown that D-mannose is usually safe for most adults when taken orally for up to six months. Some individuals might experience mild side effects such as diarrhea or nausea. However, reliable information about its safety for use beyond six months is lacking. While researchers are studying D-mannose for preventing urinary tract infections (UTIs), some studies suggest it may not be more effective than other treatments. Consulting a healthcare provider about any concerns before joining a trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for urinary tract infections, which often involve antibiotics, D-mannose stands out as a natural sugar. Researchers are excited because D-mannose works by preventing bacteria from sticking to the walls of the urinary tract, potentially reducing infection without the side effects of antibiotics. This makes it a promising option for those seeking a gentler, more natural approach to managing UTIs.

What evidence suggests that D-mannose might be an effective treatment for recurrent urinary tract infections?

Research has shown mixed results for D-mannose in preventing repeat urinary tract infections (UTIs). One study found that individuals taking D-mannose went an average of 200 days before experiencing another UTI, compared to 52.7 days for those on antibiotics. However, other studies suggest D-mannose may not be effective for women who frequently experience these infections. Specifically, it did not help postmenopausal women avoid UTIs or extend the time between infections. Overall, evidence on D-mannose's effectiveness remains inconsistent, showing promise in some cases but not in others. Participants in this trial will receive either D-mannose or a placebo to further evaluate its effectiveness. ^{2 4 6 7 8}

Who Is on the Research Team?

Philippe Zimmern, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/fullarticle/2817488

d-Mannose for Prevention of Recurrent Urinary Tract ...

Primary outcome data were available for 583 participants (97.5%). The proportion contacting ambulatory care with a clinically suspected UTI was ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8944421/

Why d-Mannose May Be as Efficient as Antibiotics ...

In the group treated with d-mannose, a significantly increased mean time to UTI recurrence (200 days) was observed in comparison to the antibiotic group (52.7 ...

3.

evidence.nihr.ac.uk

evidence.nihr.ac.uk/alert/d-mannose-does-not-prevent-urinary-tract-infections-utis/

D-mannose does not prevent urinary tract infections (UTIs)

The study suggests that D-mannose is not effective at preventing urinary tract infections (UTIs) in women who have frequent infections.

4.

journals.lww.com

journals.lww.com/jasn/fulltext/2024/10001/safety_and_efficacy_of_d_mannose_as_prophylaxis_of.443.aspx

Safety and Efficacy of D-mannose as Prophylaxis of Urinary...

Further analyses showed that D-mannose did not reduce time to recurrence of UTI and did not improve outcomes in postmenopausal women.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01808755

D Mannose in Recurrent Urinary Tract Infections

Women with frequent reinfections have a rate of 0.13 to 0.22 UTIs per month (1.6 to 2.6 infections per year). For premenopausal, healthy, and active females, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9427198/

D‐mannose for preventing and treating urinary tract infections

D‐mannose (2 g) had uncertain effects on symptomatic and bacteriuria‐confirmed UTIs when compared to no treatment (1 study, 205 participants; very low certainty ...

7.

webmd.com

webmd.com/vitamins/ai/ingredientmono-1114/d-mannose

D-Mannose - Uses, Side Effects and More

When taken by mouth: D-mannose is possibly safe for most adults when taken for up to 6 months. It can cause diarrhea and nausea. There isn't enough reliable ...

8.

nutritionj.biomedcentral.com

nutritionj.biomedcentral.com/articles/10.1186/s12937-022-00769-x

Role of D-mannose in urinary tract infections - Nutrition Journal

Research suggests that supplemented D-mannose could be a promising alternative or complementary remedy especially as a prophylaxis for recurrent UTIs.