Uqora Supplements in Women With UTIs

Urinary Tract Infections Clinical Trial

Official title:

Evaluation of the Impact of the Uqora Dietary Supplement Products on Urinary Tract Infection (UTI) Incidence in Women With Recurring UTIs

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04024046
• Other study ID #: Pro00034128
• Status: Terminated
• Start date: April 18, 2019
• Est. completion date: September 16, 2020

Study information

• Verified date: September 2022
• Source: Hawthorne Effect Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a virtual study which will invite females over the age of 18 who have had 2 or more UTIs in the past 6 months to participate. The investigators are looking at the impact of a daily dietary supplement with the recurrence of UTIs. Participants will be blinded and randomized randomized into the Control Group or Groups 1 or 2. Control Group will receive a Placebo Drink-Mix and Placebo Capsules. Group 1 will receive the Uqora Drink-Mix and Placebo Capsules. Group 2 will receive the Uqora Drink-Mix and Uqora Capsules. Each group will receive 180 day supply of the products.

Description:

Urinary Track Infections (UTIs) are the second most common infection in the United Stated. There is growing concern about the amount of antibiotic use and drug resistance. Patients with frequent UTIs are encouraged to keep well hydrated. Some are encouraged to drink cranberry juice or cranberry extract. In 2016 a published study demonstrated no difference. The investigators hypothesize that the Uqora dietary supplement will decrease the frequency of UTIs.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 360
• Est. completion date: September 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is female

• 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:

• Has any of the following medical conditions: multiple sclerosis; diabetes; chronic kidney stones ? Subjects with multiple sclerosis, diabetes, and/ or chronic kidney stones will be excluded from the study because these subjects are more likely to have complicated UTIs.

• 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.

Related Conditions & MeSH terms

• Infections
• Urinary Tract Infections

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United States	Uqora, Inc.	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Hawthorne Effect Inc.	Uqora, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (18)

Altarac S, Papeš 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. — View Citation

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. Review. — View Citation

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. — View Citation

Foxman B, Chi JW. Health behavior and urinary tract infection in college-aged women. J Clin Epidemiol. 1990;43(4):329-37. — View Citation

Head KA. Natural approaches to prevention and treatment of infections of the lower urinary tract. Altern Med Rev. 2008 Sep;13(3):227-44. Review. — View Citation

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 C — View Citation

Ku, Ja Hyeon and Oh, Seung-June. Comparison of Three Quality of Life Questionnaires in Urinary Incontinence. Springer Science and Business Media. 2010.

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 — View Citation

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. — View Citation

Ochoa-Brust GJ, Fernández AR, Villanueva-Ruiz GJ, Velasco R, Trujillo-Hernández B, Vásquez 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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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 1 — View Citation

Trujillo J, Chirino YI, Molina-Jijón E, Andérica-Romero AC, Tapia E, Pedraza-Chaverrí J. Renoprotective effect of the antioxidant curcumin: Recent findings. Redox Biol. 2013 Sep 17;1:448-56. doi: 10.1016/j.redox.2013.09.003. Review. — View Citation

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. Review. Corrected and republished in: Int J Antim — View Citation

Yaxley, Julian. "Alkalization of urine in patients with infections of the urinary tract." British Journal of Medicine and Medical Research. 2016.

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of UTIs at six-months	A UTI is defined by the receipt of a prescription of antibiotics for treatment	6-months

External Links

•   The Core Elements of Antibiotic Stewardship for Nursing Homes
•   Urinary Tract Infections
•   Urologic Diseases in America