Host-microbiota-environment Interactions

Recruiting

• Conditions: Juvenile Idiopathic Arthritis; Inflammatory Bowel Diseases; Diabetes type1
• Interventions: Other: Stool sample

• Registration Number: NCT05176795
• Lead Sponsor: University Hospital, Clermont-Ferrand

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)

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-04
• Study Start: 2022-03-16
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22
• Primary Completion: 2026-03
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

CASE:

• Newly diagnosed with JIA, IBD or T1DM

CONTROL:

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	Stool sample	Child under 10 years old newly diagnosed with JIA, IBD or T1DM
Active Comparator: Healthy control	Stool sample	Brother/sister of child with pediatric onset inflammatory disease (same age category - same environment: food, living space)

Primary Outcome Measures

Name	Time	Method
Gut microbiota composition	12 months	Variation between cases and controls in gut microbiota composition (determination of the gut microbiota composition by 16S metagenomic)

Secondary Outcome Measures

Name	Time	Method
Variation in gut microbiota following initiation of therapy in patients newly diagnosed with JIA, IBD or T1DM.	Day 1, 2 months, 12 months	Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA
Tryptasemia	Day 1, 2 months, 12 months	Variation in plasma tryptase levels during the first year of the disease
Composition of the fecal volatolome	Day 1	The volatile compounds in the samples will be analyzed via solid-phase microextraction (SPME) coupled with gas chromatography-mass spectrometry (GC-MS)
Fecal contamination with nanoparticles	Day 1	measurement of titane and silicia levels in stool sample

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France