D‑mannose and vitamin drink mix for urinary health in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, three-arm trial will follow adult biological females with recurrent uncomplicated UTIs for six months after enrollment and randomize them to one of three groups to receive a dietary supplement drink mix or comparison regimens. The investigational product contains D‑mannose, vitamins, and electrolytes intended to reduce bacterial adhesion and support hydration and urinary pH. Participants must be 18–75, within seven days of an acute UTI, have a history of ≥2 UTIs in 6 months or ≥3 in 12 months, and have smartphone/Wi‑Fi access, while pregnant or lactating persons and those using other concurrent treatments are excluded. Outcomes include urinary health measures and safety endpoints to determine whether the non‑antibiotic approach can reduce factors linked to recurrent UTIs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy biological females who are 18-75 years of age (inclusive).
2. Have a history of recurrent uncomplicated UTI (≥2 UTIs in the last 6 months and/or ≥3 UTIs in the last 12 months).
3. Are within 7 days of the enrollment trigger event (acute UTI).
4. In good general health (no active or uncontrolled diseases or conditions besides recurrent UTIs) and able to consume the study product.
5. BMI 18.5-39.9 kg/m\^2
6. Have reliable, stable access to Wi-Fi and a smart phone/device.
7. Willing and able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read questionnaires, and able to carry out all study-related procedures.

Exclusion Criteria:

1. Individuals who are lactating, pregnant, or planning to become pregnant during the study.
2. Active participation in a clinical trial.
3. Use of any treatment for menopausal outcomes or other concomitant treatments.
4. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
5. History of hyperkalemia (high potassium).
6. History of Chronic Kidney Disease.
7. Introduction of antibiotics unrelated to a UTI occurrence during the trial period.
8. Current use of D-mannose (participants may complete a 2-week washout period).
9. Has previously used the FLUSH product.
10. Current use of antibiotic-based prophylaxis.
11. History of Diabetes mellitus (Type 1 and/or 2).
12. Use of vaginal and/or local estrogen therapy (permitted if stable dose longer than 90 days).
13. Active or suspected vaginitis.
14. Started a new nonantibiotic-based prophylaxis within the last 90 days.
15. Use of probiotics (permitted if orally administered with stable dose longer than 90 days).
16. Use of indwelling or intermittent urinary catheterization.
17. Diagnosis of overactive bladder (OAB) or interstitial cystitis /bladder pain syndrome (IC/BPS).
18. Urologic procedure within 6 months prior to trial enrollment.
19. History of structural urinary tract disease.
20. History of Lichen sclerosis.
21. Use of potassium-sparing medications. o E.g., Spironolactone (used for PCOS) (potassium-sparing diuretic); ACE inhibitors and ARBs; systemic calcineurin inhibitors.

Where it's running

• Bonafide Health
  Harrison, New York, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Urine Sample Biobank for Adults Using Intermittent Catheters

  This study tests whether collecting and storing urine samples from adults who use intermittent catheterization, with and without recent UTIs, can build a biobank for future research without changing their standard care.

  Recruiting Coloplast A/S · Humlebæk · NCT07769606

• Risk factors for double-J stent bacterial colonization and its clinical implications

  This study looks at which factors make double-J ureteral stents more likely to harbor bacteria and what that means for infections and symptoms.

  Recruiting Al-Azhar University · Cairo · NCT07740811

• Standing in the shower versus sitting on the toilet to reduce leftover urine after catheter removal in women after benign vaginal surgery

  Test whether standing in the shower instead of sitting on the toilet reduces leftover urine and pain after catheter removal in adult women who had benign vaginal gynecologic surgery.

  Recruiting Assuta Ashdod Hospital · Ashdod and 1 other locations · NCT07372547

• D-mannose to prevent recurrent urinary tract infections in post-menopausal women.

  This trial will test whether taking 2 g of D-mannose daily prevents recurrent urinary tract infections in post‑menopausal women.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT06940622

• Evaluating infection control programs for urinary tract infections at Sohag University Hospital

  This study is testing whether a new infection control program can help lower the number of urinary tract infections in adults who need catheters while in the hospital.

  Recruiting Sohag University · Sohag, Sohag Governorate · NCT06859814

• Evaluating antibiotic use before onabotulinumtoxinA injections for overactive bladder

  This study is testing if giving antibiotics before onabotulinumtoxinA injections helps or is needed for adults with overactive bladder who haven't found relief from other treatments.

  Recruiting Benaroya Research Institute · Stony Brook, New York · NCT04754737

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.