Uqora Supplements in Women With UTIs

September 26, 2022 updated by: Hawthorne Effect Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92116
        • Uqora, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control - Placebo
  1. Placebo Drink-Mix Daily for 180 days
  2. Placebo Capsules Daily for 180 days
Dietary supplement: Uqora
Participants will receive 1 Placebo Drink-Mix and 2 Placebo Capsules Daily
Other Names:
  • Placebo
Group 1
  1. Uqora Drink-Mix Daily for 180 days
  2. Placebo Capsules Daily for 180 days
Dietary supplement: Group1
Participants will receive 1 Uqora Drink-Mix and 2 Placebo Capsules Daily
Group 2
  1. Uqora Drink-Mix Daily for 180 days
  2. Uqora Capsules Daily for 180 days
Dietary supplement: Group 2
Participants will receive 1 Uqora Drink-Mix and 2 Uqora Capsules Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of UTIs at six-months
Time Frame: 6-months
A UTI is defined by the receipt of a prescription of antibiotics for treatment
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawthorne Effect Inc.

Collaborators

Uqora, Inc.

Investigators

  • Principal Investigator: Martina Speight, MSN, FNP-BC, Hawthorne Effect Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2019

Primary Completion (Actual)

September 16, 2020

Study Completion (Actual)

September 16, 2020

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 16, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00034128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data will be owned by the Sponsor, Uqora Inc. The data will be collected, analyzed and given to the sponsor.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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