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Host-microbiota-environment Interactions (MIP-1)

U

University Hospital, Clermont-Ferrand

Status

Enrolling

Conditions

Diabetes type1
Inflammatory Bowel Diseases
Juvenile Idiopathic Arthritis

Treatments

Other: Stool sample

Study type

Observational

Funder types

Other

Identifiers

NCT05176795
2021-AO1006-35 (Other Identifier)
RNI 2021 MERLIN

Details and patient eligibility

About

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.

Full 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)

Enrollment

60 estimated patients

Sex

All

Ages

Under 10 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Lise LACLAUTRE

Data sourced from clinicaltrials.gov

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