Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494826
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-02
Brief Title:
Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohns Disease
Sponsor:
Weizmann Institute of Science
Organization:
Weizmann Institute of Science
Study Overview
Official Title:
Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohns Disease
Status:
RECRUITING
Status Verified Date:
2024-03
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:
In this study the investigators will explore our protein-based platform assessing commensals potentially contributing to features of CD while assessing the global composition and abundance of AMPs expressed in the GI tract under specific CD-relevant clinical contexts This would enable us to a identify new commensals contributing to features of CD spectrum and various sub-types b uncover the mechanistic basis of dysbiosis in CD c utilize the pipeline to develop new theranostic for disease exacerbation complication and treatment responses and d potentially enable future exploitation of novel AMP combinations and their respective antimicrobial capacity to counteract dysbiosis in CD
Uncovering the proteomic manifestations of perturbed host-microbiome communications in CD will eventually enable the development and validation of clinical non-invasive surrogate markers mechanistically determine causative drivers of CD and potentially facilitate the development of novel therapeutic interventions
Uncovering the proteomic manifestations of perturbed host-microbiome communications in CD will eventually enable the development and validation of clinical non-invasive surrogate markers mechanistically determine causative drivers of CD and potentially facilitate the development of novel therapeutic interventions
Detailed Description:
Participants will be recruited from a community outpatient clinics and from a leading outpatient gastroenterology clinic Emek Medical Center after ICF signing they will fill out a medical demographic and lifestyle habits questionnaires as well as a food frequency questionnaire FFQ Participants will receive a home stool kit and will be instructed on how to use it They will also receive a kit and an explanation regarding preparation materials for the colonoscopy Subjects will be asked to collect stool samples at home - prior to colonoscopy and if possible - after colonoscopy bowel prep
The seconed visit of the study will occure on the day of colonoscopy Each patient will be clinically assessed by a gastroenterologist using the Crohns Disease Activity Index CDAI30 and Harvey-Bradshaw Index HBI and collection of luminal brush cytology and mucosal samples from 4 different lower intestine regions
The seconed visit of the study will occure on the day of colonoscopy Each patient will be clinically assessed by a gastroenterologist using the Crohns Disease Activity Index CDAI30 and Harvey-Bradshaw Index HBI and collection of luminal brush cytology and mucosal samples from 4 different lower intestine regions
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