Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04496726
Status:
TERMINATED
Last Update Posted:
2024-01-12
First Post:
2020-07-29
Brief Title:
Cranberry and Quillaja on Symptoms of Uncomplicated UTI
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
A Proof-of-concept Feasibility Study to Investigate the Effect of Cranberry and Quillaia Extract Type II on Symptoms in Women With Uncomplicated Urinary Tract Infection and to Study the Modulation of the Urinary and Gut Microbiome Pre- and Post-antibiotic Use
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to recruit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the effects of cranberry and quillaja capsules on symptoms of uncomplicated urinary tract infections
Detailed Description:
Urinary tract infection UTI is one of the most common bacterial infections in humans and it disproportionately affects women Currently there are only a few alternatives to antibiotics for treatment of UTI Although symptomatic relief occurs more quickly in women treated with oral antibiotics for uncomplicated UTIs patients appear to successfully resolve their UTI without antibiotic therapy While antibiotics are the mainstay of therapy there are growing concerns about collateral effects impacting healthy microbiomes and anti-bacterial resistance patterns Recent estimates from the CDC indicate that more than 28 million antibiotic-resistant infections occur in the US each year and more than 35000 people die as a result
The proposed research fills a key knowledge gap that will be critical in determining the role of a non-antibiotic substance with the potential to treat UTIs by modulating the urinary and gut microbiome to restore health and minimize the reliance on traditional antibiotic therapy while also preventing antibiotic resistance In addition this study will provide early evidence of the short-term symptom and urinary and gut microbiome changes following ingestion of two botanical food substances cranberry and quillaja that have the potential for beneficial effects on the microbiome and UTI symptoms
The proposed research fills a key knowledge gap that will be critical in determining the role of a non-antibiotic substance with the potential to treat UTIs by modulating the urinary and gut microbiome to restore health and minimize the reliance on traditional antibiotic therapy while also preventing antibiotic resistance In addition this study will provide early evidence of the short-term symptom and urinary and gut microbiome changes following ingestion of two botanical food substances cranberry and quillaja that have the potential for beneficial effects on the microbiome and UTI symptoms
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?:
None
Is an FDA AA801 Violation?:
None