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Urinary TractNCT07856550

Evaluating the Efficacy of the Flush Advanced+ Dietary Supplement Drink Mix Compared to a Placebo in Women Ages 18-75 With a History of Recurrent, Bothersome Urinary Tract Symptoms

A study testing Flush Advanced+ Dietary Drink Mix in people with Urinary Tract, run by Bonafide Health at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the efficacy of the Flush Advanced+ dietary drink mix to reduce bothersome urinary tract symptoms compared to a placebo. The main questions it aims to answer are: Does the Flush Advanced+ dietary drink mix reduce the number of episodes bothersome urinary tract symptoms… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Urinary Tract
What is being tested?
Flush Advanced+ Dietary Drink Mix
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteUnited States
Study dates
16 Mar 2026to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Healthy biological females who are 18-75 years of age (inclusive).
  • Have a body mass index (BMI) between 18.5 to 39.9 kg/m2 (inclusive).
  • Have a history of recurrent, bothersome urinary tract symptom episodes.
  • * >5 bothersome urinary tract symptom episodes in the past 6 months OR >7 in the past 12 months will be excluded
  • Are not experiencing symptoms from a bothersome urinary tract symptom episode.
  • In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
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  • Have reliable, stable access to Wi-Fi and a smartphone/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.
  • English speaking.

Who cannot join

  • 1. Individuals who are lactating, pregnant, or planning to become pregnant during the study.
  • 2. Seeking enrollment in another clinical trial or active participation in a clinical trial.
  • 3. >5 bothersome urinary tract symptom episodes in the past 6 months OR >7 in the past 12 months.
  • 4. Use of anticoagulants (e.g., warfarin) in the past 30 days. 5. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
  • 6. History of hyperkalemia (high potassium). 7. History of Chronic Kidney Disease, kidney infections, or nephrolithiasis (kidney stones).
  • 8. History of hospitalization for urologic or urinary tract symptoms. 9. History of recurrent bothersome urinary tract symptom episodes accompanied by symptoms indicative of more complications, such as recurrent fever, vomiting, chills, flank pain, visible blood in urine, and pain radiating down the legs 10. Introduction of antibiotics unrelated to a urological occurrence during the study period.
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  • 11. Current use of D-mannose. 12. Current use of cranberry supplements or cranberry juice or use of cranberry supplements of juice in 4 weeks prior to enrollment.
  • 13. Has previously used the Flush Advanced+ product. 14. Current use of antibiotic-based prophylaxis or use of antibiotics within 2 weeks of enrollment.
  • 15. History of Diabetes mellitus (Type 1 and/or 2). 16. Individuals who are immunocompromised, including those with known immunodeficiency disorders or receiving chronic immunosuppressive therapy (e.g., corticosteroids, chemotherapy, biologic agents).
  • 17. History of cancer within two years prior to enrollment. 18. Use of vaginal and/or local estrogen therapy (permitted if stable dose longer than 90 days).
  • 19. Active or suspected vaginitis. 20. Started a new nonantibiotic-based prophylaxis within the last 90 days. 21. Use of probiotics (permitted if orally administered with stable dose longer than 90 days).
  • 22. Use of indwelling or intermittent urinary catheterization. 23. Diagnosis of overactive bladder (OAB) or interstitial cystitis / bladder pain syndrome (IC/BPS).
  • 24. Urologic procedure within 6 months prior to trial enrollment or with a planned urological procedure in the 6 months following enrollment.
  • 25. Any urologic or gynecologic surgical history that could cause or exacerbate urinary tract symptoms.
  • 26. History of structural urinary tract disease or abnormalities. 27. History of Lichen sclerosis. 28. Use of potassium-sparing medications.
  • E.g., Spironolactone (used for PCOS) (potassium-sparing diuretic); ACE inhibitors and ARBs; systemic calcineurin inhibitors.
  • 39. Use of statins. 30. Use of Vitamin C if the total daily amount consumed (including the amount in Flush Advanced+) meets or surpasses the tolerable upper intake level (UL) for adult females of 2,000 mg, per NIH guidelines 31. Use of Vitamin B6 if the total daily amount consumed (including the amount in Flush Advanced+) meets or surpasses the tolerable upper intake level (UL) for adult females of 100 mg, per NIH guidelines 32. Use of methenamine (permitted if stable dose longer than 90 days).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Bonafide Health

    Harrison, New York, 10528

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy of the Flush Advanced+ Dietary Supplement Drink Mix to Improve Urinary Health Measures

The goal of this clinical trial is to evaluate the efficacy of the Flush Advanced+ dietary drink mix to reduce bothersome urinary tract symptoms compared to a placebo. The main questions it aims to answer are:

  • Does the Flush Advanced+ dietary drink mix reduce the number of episodes bothersome urinary tract symptoms over the course of six months compared to a placebo?
  • Does the Flush Advanced+ dietary drink mix reduce the severity of bothersome urinary tract symptoms? Researchers will compare the Flush Advanced+ dietary drink mix to a placebo (a look-alike substance that contains no active ingredients) to determine if the Flush Advanced+ dietary drink mix reduces the frequency and severity of bothersome urinary tract symptoms.
Read more

Participants will:

  • Take the Flush Advanced+ dietary drink mix or a placebo every day for approximately 6 months
  • Complete electronic daily diaries to capture any acute episodes of bothersome urinary tract symptoms
  • Complete electronic questionnaires every other week to capture any bothersome urinary tract symptoms and urinary health-related quality of life measures
  • Complete check-in phone calls with a research team member every other month
Read the detailed description

Urologic health problems can significantly impact quality of life in women and can affect overall well-being, social relationships, sexual relationships, and physical activity. While prescription antibiotics are commonly used to treat problems related to urologic health, many women seek alternatives to prescription medications and are interested in supporting their urinary tract health using dietary supplements.

Non-antibiotic approaches, such as D-mannose, cranberry, vitamins, and hydration support have demonstrated potential in mitigating bothersome urinary tract symptoms. D-mannose may prevent E. coli from adhering to the urinary tract, while Pacran® whole cranberry fruit powder has shown to significantly reduce the incidence of urologic health problems, such as urinary tract infections (UTIs), as well as and the incidence of UTIs with urinary frequency and urgency symptoms. Adequate hydration and the balance of key electrolytes, including potassium, calcium, and magnesium, may promote the flushing of bacteria from the urinary tract.

This clinical trial aims to evaluate the efficacy of Flush Advanced+, a dietary supplement drink mix containing D-mannose, Pacran® whole cranberry fruit powder, vitamins, and electrolytes, in improving urinary health outcomes. By targeting the mechanisms involved in UTI pathogenesis - such as bacterial adhesion and urinary pH regulation - this trial seeks to provide support for bothersome urinary tract symptom episodes that can significantly impact women's health and quality of life.

The purpose of this double-blind, placebo-controlled study is to evaluate the efficacy and safety of Flush Advanced+ in supporting urinary tract health for women aged 18-75. Flush Advanced+ is a commercially available product.

Conditions
Urinary Tract
Being tested
Flush Advanced+ Dietary Drink Mix, Placebo Dietary Drink Mix
Keywords
urinary tract, urinary health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flush Advanced+ Dietary Drink MixDietary supplement

    Flush Advanced+ dietary drink mix containing Pacran cranberry whole fruit powder, D-mannose, vitamins, and electrolytes

  • Placebo Dietary Drink MixDietary supplement

    Drink mix with identical or similar appearance and taste as Flush Advanced+ but contains no active ingredients

Study groups in NCT07856550
Study groupRoleWhat they receive
Flush Advanced+Active comparatorFlush Advanced+ dietary drink mix
Receives: Dietary Supplement: Flush Advanced+ Dietary Drink Mix
PlaceboPlacebo comparatorPlacebo dietary drink mix containing no active ingredients
Receives: Dietary Supplement: Placebo Dietary Drink Mix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary Tract Symptom Episode Incidence

    Total number of participant-reported episodes of bothersome urinary tract symptoms

    Measured: From enrollment to the end of intervention at 6 months

  2. Impression of Improvement in Urinary Tract Health

    Overall impression of improvement in urinary tract health, as measured by the Patient Global Impression of Change (PGIC) at Month 2, Month 4, and Month 6. The PGIC is a 1-item, 7-point Likert scale ranging from 1 (Very Much Improved) to 7 (Very Much Worse), where a higher score indicates worse outcomes.

    Measured: From enrollment to the end of intervention at 6 months

Secondary outcomes (6)
  1. Sex-Triggered Urinary Tract Symptom Episode Incidence

    Total number of participant-reported urinary tract symptom episodes that participants report were triggered by sexual activity

    Measured: From enrollment to the end of intervention at 6 months

  2. Antibiotic Use for Urinary Tract Symptom Episodes

    Total number of courses of antibiotics taken for bothersome urinary tract symptom episodes

    Measured: From enrollment to the end of intervention at 6 months

  3. Good versus Bad Urinary Health Days

    Ratio of self-reported 'good' vs. 'bad' vs. 'neither good nor bad' urinary health days assessed via daily diaries. The diary contained a 1-item, 3-point Likert scale ranging from 1 (Bad) to 3 (Good), where a higher score indicates better outcomes.

    Measured: From enrollment to the end of intervention at 6 months

  4. Urinary Health-Related Quality of Life

    Change in quality of life as it relates to urinary tract health, as measured by an approved, modified version of the Recurrent Urinary Tract Infection Impact Questionnaire (RUTIIQ) every other week. The RUTIIQ is an 18-item questionnaire measured on a 11-point Likert scale ranging from 0 (Strongly Disagree) to 10 (Strongly Agree), where a higher score indicates better outcomes.

    Measured: From enrollment to the end of intervention at 6 months

  5. Product Experience

    Assess women's experience using the product, as measured by an internally-developed Product Experience Questionnaire (PEQ) monthly. The PEQ is 20-item questionnaire measured on a 4-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree), where a higher score indicates a more favorable experience.

    Measured: From enrollment to the end of intervention at 6 months

  6. Symptom severity at the time of an acute bothersome urinary tract symptom episode

    Bothersome urinary tract symptom episode, as measured by the Urinary Tract Infection - Symptom Impairment Questionnaire (UTI-SIQ-8) and Recurrent Urinary Tract Infection Symptom Scale, section C (RUTISS-C.) The UTI-SIQ-8 is an 8-item questionnaire measured on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very strong), where a higher score indicates worse outcomes.. The RUTISS-C is an 11-item questionnaire measured on an 11-point Likert scale ranging from 0 (Not Present) to 10 (Extremely Severe), where a higher score indicates worse outcomes.

    Measured: Daily for 7 days starting at the onset of bothersome urinary tract symptoms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2026
  2. Study start16 Mar 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07856550
Sponsor's protocol ID
BH-FADV-001
Status last verified
Sep 2026
First submitted
15 Sep 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vostalova J, Vidlar A, Simanek V, Galandakova A, Kosina P, Vacek J, Vrbkova J, Zimmermann BF, Ulrichova J, Student V. Are High Proanthocyanidins Key to Cranberry Efficacy in the Prevention of Recurrent Urinary Tract Infection? Phytother Res. 2015 Oct;29(10):1559-67. doi: 10.1002/ptr.5427. Epub 2015 Aug 13.

    PubMed 26268913
  • Ochoa-Brust GJ, Fernandez AR, Villanueva-Ruiz GJ, Velasco R, Trujillo-Hernandez B, Vasquez C. Daily intake of 100 mg ascorbic acid as urinary tract infection prophylactic agent during pregnancy. Acta Obstet Gynecol Scand. 2007;86(7):783-7. doi: 10.1080/00016340701273189.

    PubMed 17611821
  • Anger J, Lee U, Ackerman AL, Chou R, Chughtai B, Clemens JQ, Hickling D, Kapoor A, Kenton KS, Kaufman MR, Rondanina MA, Stapleton A, Stothers L, Chai TC. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol. 2019 Aug;202(2):282-289. doi: 10.1097/JU.0000000000000296. Epub 2019 Jul 8.

    PubMed 31042112
  • Shen AL, Lin HL, Lin HC, Tseng YF, Hsu CY, Chou CY. Urinary tract infection is associated with hypokalemia: a case control study. BMC Urol. 2020 Jul 20;20(1):108. doi: 10.1186/s12894-020-00678-3.

    PubMed 32690002
  • Hooton TM, Vecchio M, Iroz A, Tack I, Dornic Q, Seksek I, Lotan Y. Effect of Increased Daily Water Intake in Premenopausal Women With Recurrent Urinary Tract Infections: A Randomized Clinical Trial. JAMA Intern Med. 2018 Nov 1;178(11):1509-1515. doi: 10.1001/jamainternmed.2018.4204.

    PubMed 30285042
  • Kyriakides R, Jones P, Somani BK. Role of D-Mannose in the Prevention of Recurrent Urinary Tract Infections: Evidence from a Systematic Review of the Literature. Eur Urol Focus. 2021 Sep;7(5):1166-1169. doi: 10.1016/j.euf.2020.09.004. Epub 2020 Sep 22.

    PubMed 32972899
  • Ala-Jaakkola R, Laitila A, Ouwehand AC, Lehtoranta L. Role of D-mannose in urinary tract infections - a narrative review. Nutr J. 2022 Mar 22;21(1):18. doi: 10.1186/s12937-022-00769-x.

    PubMed 35313893
  • Jerkovic I, Bukic J, Leskur D, Seselja Perisin A, Rusic D, Bozic J, Zuvela T, Vuko S, Vukovic J, Modun D. Young Women's Attitudes and Behaviors in Treatment and Prevention of UTIs: Are Biomedical Students at an Advantage? Antibiotics (Basel). 2023 Jun 26;12(7):1107. doi: 10.3390/antibiotics12071107.

    PubMed 37508203
  • Laws M, Shaaban A, Rahman KM. Antibiotic resistance breakers: current approaches and future directions. FEMS Microbiol Rev. 2019 Sep 1;43(5):490-516. doi: 10.1093/femsre/fuz014.

    PubMed 31150547
  • Losada L, Amundsen CL, Ashton-Miller J, Chai T, Close C, Damaser M, DiSanto M, Dmochowski R, Fraser MO, Kielb SJ, Kuchel G, Mueller ER, Parker-Autry C, Wolfe AJ, Mallampalli MP. Expert Panel Recommendations on Lower Urinary Tract Health of Women Across Their Life Span. J Womens Health (Larchmt). 2016 Nov;25(11):1086-1096. doi: 10.1089/jwh.2016.5895. Epub 2016 Jun 10.

    PubMed 27285829

Questions about this trial

What is this clinical trial studying?

A study testing Flush Advanced+ Dietary Drink Mix in people with Urinary Tract, run by Bonafide Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary Tract Symptom Episode Incidence (time frame: From enrollment to the end of intervention at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07856550, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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