Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324591
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-02-22
Brief Title:
Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohns Disease Patients
Sponsor:
Meyer Childrens Hospital IRCCS
Organization:
Meyer Childrens Hospital IRCCS
Study Overview
Official Title:
Multicentre Observational Cohort Study in Newly Diagnosed Crohns Disease Patients Aimed at Identifying Intestinal Microbial Profiles Correlated With Low and High Risk of Severe Disease Course
Status:
ACTIVE_NOT_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:
Crohns disease CD a chronic inflammatory disease affecting the intestine is characterised by a relapsing course In 25 of cases the onset of this disease occurs in childhood Relevant studies have provided evidence of a key role of gut microbial communities the microbiota in triggering or maintaining active gut inflammation pointing to gut dysbiosis as the main event disrupting the balance of microbial communities Recent evidence suggests that in addition to the bacterial component the commensal fungal component also plays a crucial role in CD
The purpose of this prospective longitudinal study is to characterise the composition of intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn Disease in order to identify a possible association of specific faecal microbial profiles with a severe or mild-to-moderate disease course
The purpose of this prospective longitudinal study is to characterise the composition of intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn Disease in order to identify a possible association of specific faecal microbial profiles with a severe or mild-to-moderate disease course
Detailed Description:
None
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