Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07453693
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07453693
Study Brief:
Protocol Section:
NCT07453693