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Clinical Trials/NCT05176795
NCT05176795
Recruiting
Not Applicable

Study of the Determinants of Pediatric Onset Inflammatory Diseases: Host-microbiota-environment Interactions

University Hospital, Clermont-Ferrand1 site in 1 country60 target enrollmentMarch 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Juvenile Idiopathic Arthritis
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
60
Locations
1
Primary Endpoint
Gut microbiota composition
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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 his/her sibling(s) (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)

Registry
clinicaltrials.gov
Start Date
March 16, 2022
End Date
September 2026
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with JIA, IBD or T1DM
  • Brother/sister of child with pediatric onset inflammatory disease (same age category - same environment: diet, living environment)
  • Exclusion Criteria (case and control):
  • Child with antibiotic treatment in the 4 weeks preceding the stool sample
  • Recent digestive infectious disease (bacterial, viral, parasitic) (end of episode \< 7 days)
  • Exclusion Criteria (control): children with autoimmune or inflammatory disease

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Gut microbiota composition

Time Frame: 12 months

Variation between cases and controls in gut microbiota composition (determination of the gut microbiota composition by 16S metagenomic)

Secondary Outcomes

  • Variation in gut microbiota following initiation of therapy in patients newly diagnosed with JIA, IBD or T1DM.(Day 1, 2 months, 12 months)
  • Tryptasemia(Day 1, 2 months, 12 months)
  • Composition of the fecal volatolome(Day 1)
  • Fecal contamination with nanoparticles(Day 1)

Study Sites (1)

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