Urinary Tract InfectionsNCT04024046
Uqora Supplements in Women With UTIs
An observational study of Urinary Tract Infections, run by Hawthorne Effect Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Uqora, Group1 and Group 2
- Type of treatment
- Pill or oral medicine
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to 16 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of the Uqora Dietary Supplement Products on Urinary Tract Infection (UTI) Incidence in Women With Recurring UTIs
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.
Read the detailed 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Uqora, Group1, Group 2
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UqoraDietary supplement
Also called Placebo
Participants will receive 1 Placebo Drink-Mix and 2 Placebo Capsules Daily
Group1Dietary supplement
Participants will receive 1 Uqora Drink-Mix and 2 Placebo Capsules Daily
Group 2Dietary supplement
Participants will receive 1 Uqora Drink-Mix and 2 Uqora Capsules Daily
| Study group | Role | What they receive |
|---|---|---|
| Control - Placebo | 1. Placebo Drink-Mix Daily for 180 days
2. Placebo Capsules Daily for 180 days Receives: Dietary Supplement: Uqora | |
| Group 1 | 1. Uqora Drink-Mix Daily for 180 days
2. Placebo Capsules Daily for 180 days Receives: Dietary Supplement: Group1 | |
| Group 2 | 1. Uqora Drink-Mix Daily for 180 days
2. Uqora Capsules Daily for 180 days Receives: Dietary Supplement: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of UTIs at six-months
A UTI is defined by the receipt of a prescription of antibiotics for treatment
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start18 Apr 2019
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawthorne Effect Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Uqora, Inc.
- Responsible party
- Sponsor
- Investigators
- Martina Speight, MSN, FNP-BC, Principal investigator, Hawthorne Effect Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024046
- Sponsor's protocol ID
- Pro00034128
- Status last verified
- Sep 2022
- First submitted
- 16 Jul 2019
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be owned by the Sponsor, Uqora Inc. The data will be collected, analyzed and given to the sponsor.
Publications
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.
PubMed 27787564Wullt 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.
PubMed 12135844Bergsten 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.
PubMed 16238023Altarac 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.
PubMed 24215164Michaels 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.
PubMed 6346629Ofek 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.
PubMed 6120897Porru, 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.
PubMed 2324774Ochoa-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 17611821Ebrahimi 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.
PubMed 25276694Head KA. Natural approaches to prevention and treatment of infections of the lower urinary tract. Altern Med Rev. 2008 Sep;13(3):227-44.
PubMed 18950249Yaxley, 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.
PubMed 25861985Lee 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.
PubMed 12376503Reygaert 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.
PubMed 23785367
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the Uqora Dietary Supplement Products on Urinary Tract Infection (UTI) Incidence in Women With Recurring UTIs
- ClinicalTrials.gov ID
- NCT04024046
- Acronym / sponsor ID
- Pro00034128
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Hawthorne Effect Inc.University, hospital or other
- Collaborators
- Uqora, Inc.
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control - Placebo | – | Dietary Supplement: Uqora1. Placebo Drink-Mix Daily for 180 days 2. Placebo Capsules Daily for 180 days |
| Group 1 | – | Dietary Supplement: Group11. Uqora Drink-Mix Daily for 180 days 2. Placebo Capsules Daily for 180 days |
| Group 2 | – | Dietary Supplement: Group 21. Uqora Drink-Mix Daily for 180 days 2. Uqora Capsules Daily for 180 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UqoraAlso: PlaceboParticipants will receive 1 Placebo Drink-Mix and 2 Placebo Capsules Daily | Dietary supplement | Control - Placebo |
| Group1Participants will receive 1 Uqora Drink-Mix and 2 Placebo Capsules Daily | Dietary supplement | Group 1 |
| Group 2Participants will receive 1 Uqora Drink-Mix and 2 Uqora Capsules Daily | Dietary supplement | Group 2 |
Primary outcome
Recurrence of UTIs at six-months
Time frame: 6-months
A UTI is defined by the receipt of a prescription of antibiotics for treatment
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Results publication: PubMed 27787564Juthani-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.
- Results publication: PubMed 12135844Wullt 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.
- Results publication: PubMed 16238023Bergsten 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.
- Results publication: PubMed 24215164Altarac 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.
- Results publication: PubMed 6346629Michaels 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.
- Results publication: PubMed 6120897Ofek 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.
- Results publicationPorru, 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.
- Results publication: PubMed 2324774Foxman 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.
- Results publication: PubMed 17611821Ochoa-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.
- Results publication: PubMed 25276694Ebrahimi 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.
- Results publication: PubMed 18950249Head KA. Natural approaches to prevention and treatment of infections of the lower urinary tract. Altern Med Rev. 2008 Sep;13(3):227-44.
- Results publicationYaxley, Julian. "Alkalization of urine in patients with infections of the urinary tract." British Journal of Medicine and Medical Research. 2016.
- Urinary Tract InfectionsLink provided by the sponsor.
- Individual participant dataSharing planned: No. The data will be owned by the Sponsor, Uqora Inc. The data will be collected, analyzed and given to the sponsor.
Related trials for Urinary Tract Infections
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Speight, MSN, FNP-BC principal investigator
Hawthorne Effect Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Hawthorne Effect Inc. 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 Sep 2022. 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. 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?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
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?
Recurrence of UTIs at six-months (time frame: 6-months). 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 NCT04024046, which also lists 18 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 27 Sep 2022.