Ignite Creation Date:
2024-05-06 @ 1:27 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04024046
Status:
TERMINATED
Last Update Posted:
2022-09-27
First Post:
2019-07-16
Brief Title:
Uqora Supplements in Women With UTIs
Sponsor:
Hawthorne Effect Inc
Organization:
Hawthorne Effect Inc
Study Overview
Official Title:
Evaluation of the Impact of the Uqora Dietary Supplement Products on Urinary Tract Infection UTI Incidence in Women With Recurring UTIs
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Kings 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
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 Kings 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None