Uqora Supplements in Women With UTIs
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|ClinicalTrials.gov Identifier: NCT04024046|
Recruitment Status : Terminated (Sponsor Decision)
First Posted : July 18, 2019
Last Update Posted : September 27, 2022
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|Condition or disease||Intervention/treatment|
|Urinary Tract Infections||Dietary Supplement: Uqora Dietary Supplement: Group1 Dietary Supplement: Group 2|
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 Type :||Observational|
|Actual Enrollment :||360 participants|
|Official Title:||Evaluation of the Impact of the Uqora Dietary Supplement Products on Urinary Tract Infection (UTI) Incidence in Women With Recurring UTIs|
|Actual Study Start Date :||April 18, 2019|
|Actual Primary Completion Date :||September 16, 2020|
|Actual Study Completion Date :||September 16, 2020|
Control - Placebo
Dietary Supplement: Uqora
Participants will receive 1 Placebo Drink-Mix and 2 Placebo Capsules Daily
Other Name: Placebo
Dietary Supplement: Group1
Participants will receive 1 Uqora Drink-Mix and 2 Placebo Capsules Daily
Dietary Supplement: Group 2
Participants will receive 1 Uqora Drink-Mix and 2 Uqora Capsules Daily
- Recurrence of UTIs at six-months [ Time Frame: 6-months ]A UTI is defined by the receipt of a prescription of antibiotics for treatment
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Female gender as diagnosed at birth without any alterations at the time of enrollment|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
- 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.
- 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.
○ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024046
|United States, California|
|San Diego, California, United States, 92116|
|Principal Investigator:||Martina Speight, MSN, FNP-BC||Hawthorne Effect Inc.|
Publications of Results:
|Responsible Party:||Hawthorne Effect Inc.|
|Other Study ID Numbers:||
|First Posted:||July 18, 2019 Key Record Dates|
|Last Update Posted:||September 27, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||The data will be owned by the Sponsor, Uqora Inc. The data will be collected, analyzed and given to the sponsor.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Urinary Tract Infections