Uqora Supplements in Women With UTIs

NCT04024046 | Terminated

• 1 other identifier: Pro00034128
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Recurrence of UTIs at six-months

  A UTI is defined by the receipt of a prescription of antibiotics for treatment

  6-months

Study Arms (3)

Control - Placebo

1. Placebo Drink-Mix Daily for 180 days 2. Placebo Capsules Daily for 180 days

Dietary Supplement: Uqora

Group 1

1. Uqora Drink-Mix Daily for 180 days 2. Placebo Capsules Daily for 180 days

Dietary Supplement: Group1

Group 2

1. Uqora Drink-Mix Daily for 180 days 2. Uqora Capsules Daily for 180 days

Dietary Supplement: Group 2

Interventions

Uqora DIETARY_SUPPLEMENT

Participants will receive 1 Placebo Drink-Mix and 2 Placebo Capsules Daily

Also known as: Placebo

Control - Placebo

Group1 DIETARY_SUPPLEMENT

Participants will receive 1 Uqora Drink-Mix and 2 Placebo Capsules Daily

Group 1

Group 2 DIETARY_SUPPLEMENT

Participants will receive 1 Uqora Drink-Mix and 2 Uqora Capsules Daily

Group 2

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female gender as diagnosed at birth without any alterations at the time of enrollment
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will consist of 360 female subjects aged 18 and older with at least 2 UTIs in the past 6 months. The subjects will be otherwise healthy. The geography of subject enrollment will be spread across the United States.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hawthorne Effect Inc.: lead
• Uqora, Inc.: collaborator

Study Sites (1)

Uqora, Inc.

San Diego, California, 92116, United States

Location

Related Publications (18)

• 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.

  PMID: 27787564 RESULT

• 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.

  PMID: 12135844 RESULT

• 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.

  PMID: 16238023 RESULT

• 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.

  PMID: 24215164 RESULT

• 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.

  PMID: 6346629 RESULT

• 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.

  PMID: 6120897 RESULT

• 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.

  RESULT

• 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.

  PMID: 2324774 RESULT

• 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.

  PMID: 17611821 RESULT

• 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.

  PMID: 25276694 RESULT

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

  PMID: 18950249 RESULT

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

  RESULT

• 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.

  PMID: 25861985 RESULT

• 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.

  PMID: 12376503 RESULT

• 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.

  PMID: 23785367 RESULT

• 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.

  PMID: 24262582 RESULT

• 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.

  PMID: 24191240 RESULT

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

  RESULT

Related Links

• Urinary Tract Infections
• Urologic Diseases in America

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Martina Speight, MSN, FNP-BC

  Hawthorne Effect Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: April 18, 2019
• Primary Completion: September 16, 2020
• Study Completion: September 16, 2020
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)