Exploring interactions between host, microbiota, and environment in children with autoimmune diseases
Study of the Determinants of Pediatric Onset Inflammatory Diseases: Host-microbiota-environment Interactions
University Hospital, Clermont-Ferrand · NCT05176795
This study looks at how the gut bacteria and environment might affect children with autoimmune diseases like juvenile arthritis, type 1 diabetes, or inflammatory bowel diseases, by comparing them to their healthy siblings over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 0 Years to 10 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand (other) |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT05176795 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the interactions between host factors, microbiota, and environmental influences in children diagnosed with juvenile idiopathic arthritis, type 1 diabetes, or inflammatory bowel diseases. It includes an initial case-control phase, where stool samples will be collected from affected children and their healthy siblings at diagnosis, two months post-diagnosis, and one year later. The study aims to understand how early environmental events may influence the microbiotic environment and contribute to the development of these diseases.
Who should consider this trial
Good fit: Ideal candidates include children newly diagnosed with juvenile idiopathic arthritis, type 1 diabetes, or inflammatory bowel diseases.
Not a fit: Patients with recent antibiotic treatment or those with autoimmune or inflammatory diseases other than the specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the environmental and microbiotic factors that contribute to autoimmune diseases in children, potentially leading to improved prevention and treatment strategies.
How similar studies have performed: While the approach of studying microbiota and environmental interactions is gaining traction, this specific study's focus on pediatric autoimmune diseases is relatively novel.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Clermont-Ferrand
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
Study contacts
- Principal investigator: Etienne Merlin — University Hospital, Clermont-Ferrand
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Juvenile Idiopathic Arthritis, Diabetes type1, Inflammatory Bowel Diseases, microbiota, environmental factors, food contaminants