Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Uqora Supplements in Women With UTIs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04024046
Recruitment Status : Active, not recruiting
First Posted : July 18, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Uqora, Inc.
Information provided by (Responsible Party):
Hawthorne Effect Inc.

Tracking Information
First Submitted Date July 16, 2019
First Posted Date July 18, 2019
Last Update Posted Date February 17, 2020
Actual Study Start Date August 16, 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
Recurrence of UTIs at six-months [ Time Frame: 6-months ]
A UTI is defined by the receipt of a prescription of antibiotics for treatment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Urinary Tract Infections
Intervention
  • 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
Study Groups/Cohorts
  • Control - Placebo
    1. Placebo Drink-Mix Daily for 180 days
    2. Placebo Capsules Daily for 180 days
    Intervention: Dietary Supplement: Uqora
  • Group 1
    1. Uqora Drink-Mix Daily for 180 days
    2. Placebo Capsules Daily for 180 days
    Intervention: Dietary Supplement: Group1
  • Group 2
    1. Uqora Drink-Mix Daily for 180 days
    2. Uqora Capsules Daily for 180 days
    Intervention: Dietary Supplement: Group 2
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: July 16, 2019)
360
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024046
Other Study ID Numbers Pro00034128
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
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.
Responsible Party Hawthorne Effect Inc.
Study Sponsor Hawthorne Effect Inc.
Collaborators Uqora, Inc.
Investigators
Principal Investigator: Martina Speight, MSN, FNP-BC Hawthorne Effect Inc.
PRS Account Hawthorne Effect Inc.
Verification Date February 2020