Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
360 participants
OBSERVATIONAL
2019-04-18
2020-09-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nutritional Supplementation for Recurrent Urinary Tract Infections in Women
NCT03597152
Nutraceutical Efficacy for rUTI
NCT03395288
Cranberry Extract and Urinary Infection Prevention: a Clinical Trial
NCT02572895
Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)
NCT00100061
A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections
NCT06940622
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study was designed as a prospective randomized blinded study. Results will be patient reported results along with any confirmation of a documented UTI. Participants will be asked to keep a weekly diary logging the supplement intake. The participant will also be asked to complete the King's Health Questionnaire, a urinary health questionnaire and quality of life. The data will be entered by the participant into a portal using a personalized login and password.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control - Placebo
1. Placebo Drink-Mix Daily for 180 days
2. Placebo Capsules Daily for 180 days
Uqora
Participants will receive 1 Placebo Drink-Mix and 2 Placebo Capsules Daily
Group 1
1. Uqora Drink-Mix Daily for 180 days
2. Placebo Capsules Daily for 180 days
Group1
Participants will receive 1 Uqora Drink-Mix and 2 Placebo Capsules Daily
Group 2
1. Uqora Drink-Mix Daily for 180 days
2. Uqora Capsules Daily for 180 days
Group 2
Participants will receive 1 Uqora Drink-Mix and 2 Uqora Capsules Daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Uqora
Participants will receive 1 Placebo Drink-Mix and 2 Placebo Capsules Daily
Group1
Participants will receive 1 Uqora Drink-Mix and 2 Placebo Capsules Daily
Group 2
Participants will receive 1 Uqora Drink-Mix and 2 Uqora Capsules Daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Is 18 years of age or older
* Is able to swallow pills
* Has been treated with antibiotics for 2 or more UTIs in the past 6 months
* Is otherwise in good health Subjects will be deemed to be in good health if they do not report any of the existing medical conditions asked about in the screening questionnaire.
Exclusion Criteria
* Uses a wheelchair ○ Subjects that use a wheelchair will be excluded from the study as these subjects are more likely to have complicated UTIs.
* Regularly uses a catheter
○ Subjects that use catheters will be excluded from the study as these subjects are more likely to have complicated UTIs.
* Is pregnant
○ Pregnant women and women that become pregnant will be excluded from the study because of an increased likelihood these subjects will drop out from the study on recommendation from their physicians or other healthcare provider.
* Is currently taking Uqora brand products for UTI prevention
○ Subjects will be asked if they are currently taking other products for UTI prevention. If the subject indicates she is currently taking a Uqora product, she will be excluded from the study. If the subject indicates she is taking additional products for prevention (not Uqora products), she will not be excluded from the study and she will be eligible to be enrolled and randomly assigned into 1 of the 3 groups.
* Is currently taking antibiotics prophylactically for the purpose of UTI prevention ○ These subjects will be excluded from the study because they have been instructed by their physician or other healthcare provider to take antibiotics on an ongoing basis, which would have a significant impact on the recurrence of UTIs.
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Uqora, Inc.
UNKNOWN
Hawthorne Effect Inc.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martina Speight, MSN, FNP-BC
Role: PRINCIPAL_INVESTIGATOR
Hawthorne Effect Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Uqora, Inc.
San Diego, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Juthani-Mehta M, Van Ness PH, Bianco L, Rink A, Rubeck S, Ginter S, Argraves S, Charpentier P, Acampora D, Trentalange M, Quagliarello V, Peduzzi P. Effect of Cranberry Capsules on Bacteriuria Plus Pyuria Among Older Women in Nursing Homes: A Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1879-1887. doi: 10.1001/jama.2016.16141.
Wullt B, Bergsten G, Samuelsson M, Svanborg C. The role of P fimbriae for Escherichia coli establishment and mucosal inflammation in the human urinary tract. Int J Antimicrob Agents. 2002 Jun;19(6):522-38. doi: 10.1016/s0924-8579(02)00103-6. No abstract available.
Bergsten G, Wullt B, Svanborg C. Escherichia coli, fimbriae, bacterial persistence and host response induction in the human urinary tract. Int J Med Microbiol. 2005 Oct;295(6-7):487-502. doi: 10.1016/j.ijmm.2005.07.008.
Altarac S, Papes D. Use of D-mannose in prophylaxis of recurrent urinary tract infections (UTIs) in women. BJU Int. 2014 Jan;113(1):9-10. doi: 10.1111/bju.12492. No abstract available.
Michaels EK, Chmiel JS, Plotkin BJ, Schaeffer AJ. Effect of D-mannose and D-glucose on Escherichia coli bacteriuria in rats. Urol Res. 1983;11(2):97-102. doi: 10.1007/BF00256954.
Ofek I, Mosek A, Sharon N. Mannose-specific adherence of Escherichia coli freshly excreted in the urine of patients with urinary tract infections, and of isolates subcultured from the infected urine. Infect Immun. 1981 Dec;34(3):708-11. doi: 10.1128/iai.34.3.708-711.1981.
Porru, D et al. "Oral D-Mannose in recurrent urinary tract infections in women - a pilot study". Journal of Clinical Urology. Volume 7, Issue 3. 2014.
Foxman B, Chi JW. Health behavior and urinary tract infection in college-aged women. J Clin Epidemiol. 1990;43(4):329-37. doi: 10.1016/0895-4356(90)90119-a.
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.
Ebrahimi E, Khayati Motlagh S, Nemati S, Tavakoli Z. Effects of magnesium and vitamin b6 on the severity of premenstrual syndrome symptoms. J Caring Sci. 2012 Nov 22;1(4):183-9. doi: 10.5681/jcs.2012.026. eCollection 2012 Dec.
Head KA. Natural approaches to prevention and treatment of infections of the lower urinary tract. Altern Med Rev. 2008 Sep;13(3):227-44.
Yaxley, Julian. "Alkalization of urine in patients with infections of the urinary tract." British Journal of Medicine and Medical Research. 2016.
Shields-Cutler RR, Crowley JR, Hung CS, Stapleton AE, Aldrich CC, Marschall J, Henderson JP. Human Urinary Composition Controls Antibacterial Activity of Siderocalin. J Biol Chem. 2015 Jun 26;290(26):15949-60. doi: 10.1074/jbc.M115.645812. Epub 2015 Apr 10.
Lee MJ, Maliakal P, Chen L, Meng X, Bondoc FY, Prabhu S, Lambert G, Mohr S, Yang CS. Pharmacokinetics of tea catechins after ingestion of green tea and (-)-epigallocatechin-3-gallate by humans: formation of different metabolites and individual variability. Cancer Epidemiol Biomarkers Prev. 2002 Oct;11(10 Pt 1):1025-32.
Reygaert W, Jusufi I. Green tea as an effective antimicrobial for urinary tract infections caused by Escherichia coli. Front Microbiol. 2013 Jun 18;4:162. doi: 10.3389/fmicb.2013.00162. eCollection 2013.
Packiavathy IA, Priya S, Pandian SK, Ravi AV. Inhibition of biofilm development of uropathogens by curcumin - an anti-quorum sensing agent from Curcuma longa. Food Chem. 2014 Apr 1;148:453-60. doi: 10.1016/j.foodchem.2012.08.002. Epub 2012 Aug 10.
Trujillo J, Chirino YI, Molina-Jijon E, Anderica-Romero AC, Tapia E, Pedraza-Chaverri J. Renoprotective effect of the antioxidant curcumin: Recent findings. Redox Biol. 2013 Sep 17;1(1):448-56. doi: 10.1016/j.redox.2013.09.003.
Ku, Ja Hyeon and Oh, Seung-June. Comparison of Three Quality of Life Questionnaires in Urinary Incontinence. Springer Science and Business Media. 2010.
Related Links
Access external resources that provide additional context or updates about the study.
Urinary Tract Infections
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00034128
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.