Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04626362
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2020-10-15
Brief Title:
American Cranberries to Prevent UTIs in Susceptible Women
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
To Determine the Metabolic Polymorphisms of American Cranberries to Prevent UTIs in Susceptible Women Using an Integrated Metabolome-Microbiome Approach
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators pre-preliminary study showed that the urine from a portion of study participants had anti-adhesion activity The investigators propose that UTI susceptible women can be divided into responders and non-responders depending on whether cranberry intake increase anti-adhesion activity of their urine The overall objectives are to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of E coli
Detailed Description:
The American cranberries Vaccinium macrocarpon have been consumed for centuries to prevent urinary tract infections UTI which affect 50 of women in their lifetime However NIH-funded clinical trials of cranberries on UTI in the last 20 years yielded conflicting results but the reasons are unknown About 90 of UTI are initiated by adhesion of uropathogenic E coli on urinary tract epithelia It was reported that human urine after cranberry intake inhibited the adhesion of E coli A-type procyanidins and xyloglucans are the presumed bioactives in cranberries however none of these compounds are absorbable in small intestine They are degraded by microbes in colonThe pre-preliminary study showed that the urine from a portion of study participants had anti-adhesion activity suggesting there are polymorphisms in humans ability to metabolize cranberry bioactives Based on these observations the investigators formulate a novel hypothesis that not all but a fraction of women harbor specific gut microbes with the ability to catabolize cranberry bioactives to anti-adhesion metabolites in the urine therefore the variation of gut microbiome is the underlying mechanism for metabolic polymorphisms and disparity in UTI prevention The investigators propose that UTI susceptible women can be divided into responders and non-responders depending on whether cranberry intake increase anti-adhesion activity of their urine The overall objectives are to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of E coli The expected result will be to generate strong preliminary data showing the differences of gut microbiome between responders and non-responders in additional to correlations between gut microbes and candidate anti-adhesion biomarkers in the urine of UTI susceptible women
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