Ignite Creation Date:
2024-05-06 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05176795
Status:
RECRUITING
Last Update Posted:
2022-12-22
First Post:
2021-12-14
Brief Title:
Host-microbiota-environment Interactions
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Study of the Determinants of Pediatric Onset Inflammatory Diseases Host-microbiota-environment Interactions
Status:
RECRUITING
Status Verified Date:
2021-12
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:
MIP-1
Brief Summary:
Two types of inflammatory and autoimmune diseases excluding monogenic diseases can be distinguished in children those similar to adult diseases but with an early onset type 1 diabetes inflammatory diseases of the gastrointestinal tract rheumatoid arthritis with anti-CCP antibodies and those specific to children that are not described in adults early-onset juvenile idiopathic arthritis with anti-nuclear and anterior uveitis
The familial and nosological aggregations suggest that these diseases are probably polygenically determined and result from interactions with the environment In a singular way the incidence of adult diseases is increasing while the age of onset is getting earlier conversely there is no increase in early-onset juvenile idiopathic arthritis
On the other hand the influence of early events that may alter the microbiotic environment is different for different diseases whereas cesarean section or early antibiotic therapy has been shown to increase the risk of JIA and T1DM it does not seem to change the risk of IBD We hypothesize that environmental factors particularly those related to diet and bacterial and fungal digestive microbiota - are different between these disease categories
The familial and nosological aggregations suggest that these diseases are probably polygenically determined and result from interactions with the environment In a singular way the incidence of adult diseases is increasing while the age of onset is getting earlier conversely there is no increase in early-onset juvenile idiopathic arthritis
On the other hand the influence of early events that may alter the microbiotic environment is different for different diseases whereas cesarean section or early antibiotic therapy has been shown to increase the risk of JIA and T1DM it does not seem to change the risk of IBD We hypothesize that environmental factors particularly those related to diet and bacterial and fungal digestive microbiota - are different between these disease categories
Detailed Description:
Exploratory pathophysiology monocentric study including an initial case-control study followed by a cohort for cases
Controls will be siblings of cases with longitudinal follow-up
Stool samples will be collected simultaneously from the child with JIA T1DM or IBD case and hisher siblings control
at the time of diagnosis
two months after diagnosis for children with inflammatory disease only
one year after diagnosis cases and controls
Tryptase level in plasma will be recorded for the child with JIA T1DM or IBD at the time of diagnosis 2 months and 1 year after diagnosis
Controls will be siblings of cases with longitudinal follow-up
Stool samples will be collected simultaneously from the child with JIA T1DM or IBD case and hisher siblings control
at the time of diagnosis
two months after diagnosis for children with inflammatory disease only
one year after diagnosis cases and controls
Tryptase level in plasma will be recorded for the child with JIA T1DM or IBD at the time of diagnosis 2 months and 1 year after diagnosis
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 |
|---|---|---|---|
| 2021-AO1006-35 | OTHER | ANSM | None |