Clinical trial NCT04024046: Uqora Supplements in Women With UTIs
Official title: Evaluation of the Impact of the Uqora Dietary Supplement Products on Urinary Tract Infection (UTI) Incidence in Women With Recurring UTIs
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Urinary Tract Infections
Lead sponsor: Hawthorne Effect Inc.
Sponsor class: OTHER
Collaborators: name: Uqora, Inc.
First posted: 2019-07-18
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence of UTIs at six-months
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Uqora, Inc.
state: California
Study officials:
affiliation: Hawthorne Effect Inc.
name: Martina Speight, MSN, FNP-BC
role: PRINCIPAL_INVESTIGATOR
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