Ignite Creation Date:
2024-05-06 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05065008
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2021-09-29
Brief Title:
The Roles of Gut Microbiome in UTI Susceptible Women
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Investigate the Roles of Gut Microbiome in the Differential Responses of UTI Susceptible Women to Cranberry Juice Intake
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
Clinical trials on cranberry juice and UTI prevention yielded both positive and negative results for unknown reason Gut microbiome in women affect the absorption and metabolism of cranberry bioactives The variation of gut microbiome is a probable mechanism for metabolic polymorphisms and disparity in UTI prevention in women
Detailed Description:
The American cranberries especially cranberry juice have used for centuries as a folk medicine to prevent urinary tract infections UTI which affect 50 of women in their lifetime Over 40 clinical trials have been conducted in the last 20 years to verify the UTI preventatively activity of cranberry juices but the results were contradictory About 90 of UTI are initiated by the adhesion of uropathogenic E coli UPEC on urinary tract epithelia It was reported that human urine after consumption of cranberry juice inhibited the adhesion of UPEC The A-type proanthocyanidins and xyloglucans are the presumed bioactives in cranberries however this is unlikely because these two classes of compounds have extremely low bioavailability in human body Preliminary research suggested that women can be either resistant or susceptible to UTI depending on the inherent anti-adhesion activity in their urine against UPEC before consuming cranberry juice Not all but a fraction of UTI susceptible women had increased urinary anti-adhesion activity after consuming cranberry juices These women are classified as responders and others are non-responders The variation of gut microbiome is a probable mechanism for metabolic polymorphisms and disparity in UTI prevention The objective of this trials is to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of UPEC
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PRO00039868 | OTHER | UF UFIRST | None |
| IRB202102165 | OTHER | None | None |