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Tests treatment safety and results for UTI's
Official title An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement
ClinicalTrials.gov ID: NCT07453693
What this study is testing
- What it's testing
- This is a 6-month, three-arm randomized controlled trial evaluating the efficacy and safety of a dietary supplement drink mix on urinary health outcomes in adult females. Participants will be randomly assigned to one of three study arms and followed for six months to assess changes in urinary health measures.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only. Healthy volunteers may be eligible.
You may be able to join if
- Healthy biological females who are 18-75 years of age (inclusive).
- Have a history of recurrent uncomplicated UTI (≥2 UTIs in the last 6 months and/or ≥3 UTIs in the last 12 months).
- Are within 7 days of the enrollment trigger event (acute UTI).
- In good general health (no active or uncontrolled diseases or conditions besides recurrent UTIs) and able to consume the study product.
- BMI 18.5-39.9 kg/m\^2
You likely can't join if
- Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- Active participation in a clinical trial.
- Use of any treatment for menopausal outcomes or other concomitant treatments.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- History of hyperkalemia (high potassium).
- History of Chronic Kidney Disease.
See the full eligibility criteria
- Healthy biological females who are 18-75 years of age (inclusive).
- Have a history of recurrent uncomplicated UTI (≥2 UTIs in the last 6 months and/or ≥3 UTIs in the last 12 months).
- Are within 7 days of the enrollment trigger event (acute UTI).
- In good general health (no active or uncontrolled diseases or conditions besides recurrent UTIs) and able to consume the study product.
- BMI 18.5-39.9 kg/m\^2
- Have reliable, stable access to Wi-Fi and a smart phone/device.
- 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.
- Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- Active participation in a clinical trial.
- Use of any treatment for menopausal outcomes or other concomitant treatments.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- History of hyperkalemia (high potassium).
- History of Chronic Kidney Disease.
- Introduction of antibiotics unrelated to a UTI occurrence during the trial period.
- Current use of D-mannose (participants may complete a 2-week washout period).
- Has previously used the FLUSH product.
- Current use of antibiotic-based prophylaxis.
- History of Diabetes mellitus (Type 1 and/or 2).
- Use of vaginal and/or local estrogen therapy (permitted if stable dose longer than 90 days).
- Active or suspected vaginitis.
- Started a new nonantibiotic-based prophylaxis within the last 90 days.
- Use of probiotics (permitted if orally administered with stable dose longer than 90 days).
- Use of indwelling or intermittent urinary catheterization.
- Diagnosis of overactive bladder (OAB) or interstitial cystitis /bladder pain syndrome (IC/BPS).
- Urologic procedure within 6 months prior to trial enrollment.
- History of structural urinary tract disease.
- History of Lichen sclerosis.
- Use of potassium-sparing medications. o E.g., Spironolactone (used for PCOS) (potassium-sparing diuretic); ACE inhibitors and ARBs; systemic calcineurin inhibitors.
The study team makes the final eligibility decision.
Where it's taking place
- Harrison, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harrison, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.