Host-microbiota-environment Interactions

NCT05176795 | Terminated

• 2 other identifiers: RNI 2021 MERLIN2021-AO1006-35
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 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.

Conditions

Diabetes type1; Juvenile Idiopathic Arthritis; Inflammatory Bowel Diseases

Keywords

microbiota; environmental factors; food contaminants

Outcome Measures

Primary Outcomes (2)

• Gut microbiota composition

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

  Day 1

• Gut microbiota composition

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

  12 months

Secondary Outcomes (4)

• Composition of the fecal volatolome

  Day 1

• 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

• Fecal contamination with nanoparticles

  Day 1

Study Arms (2)

Experimental

Child under 10 years old newly diagnosed with JIA, IBD or T1DM

Other: Stool sample

Active Comparator: Healthy control

Brother/sister of child with pediatric onset inflammatory disease (same age category - same environment: food, living space)

Other: Stool sample

Interventions

Stool sample OTHER

Comparaison of the gut microbiota composition

Active Comparator: Healthy control; Experimental

Eligibility Criteria

• Age: 0 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The participants include patient-sibling pairs meeting the inclusion criteria (30 children newly diagnosed with JIA, IBD or T1DM and 30 siblings).

You may qualify if:

• 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)

You may not qualify if:

• Child with antibiotic treatment in the 4 weeks preceding the stool sample
• Recent digestive infectious disease (bacterial, viral, parasitic) (end of episode \< 7 days)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Related Publications (4)

• Schwiertz A, Jacobi M, Frick JS, Richter M, Rusch K, Kohler H. Microbiota in pediatric inflammatory bowel disease. J Pediatr. 2010 Aug;157(2):240-244.e1. doi: 10.1016/j.jpeds.2010.02.046. Epub 2010 Apr 18.

  PMID: 20400104 BACKGROUND

• Rouxel O, Da Silva J, Beaudoin L, Nel I, Tard C, Cagninacci L, Kiaf B, Oshima M, Diedisheim M, Salou M, Corbett A, Rossjohn J, McCluskey J, Scharfmann R, Battaglia M, Polak M, Lantz O, Beltrand J, Lehuen A. Cytotoxic and regulatory roles of mucosal-associated invariant T cells in type 1 diabetes. Nat Immunol. 2017 Dec;18(12):1321-1331. doi: 10.1038/ni.3854. Epub 2017 Oct 9.

  PMID: 28991267 BACKGROUND

• Di Paola M, Cavalieri D, Albanese D, Sordo M, Pindo M, Donati C, Pagnini I, Giani T, Simonini G, Paladini A, Lionetti P, De Filippo C, Cimaz R. Alteration of Fecal Microbiota Profiles in Juvenile Idiopathic Arthritis. Associations with HLA-B27 Allele and Disease Status. Front Microbiol. 2016 Oct 26;7:1703. doi: 10.3389/fmicb.2016.01703. eCollection 2016.

  PMID: 27833598 BACKGROUND

• Defois C, Ratel J, Garrait G, Denis S, Le Goff O, Talvas J, Mosoni P, Engel E, Peyret P. Food Chemicals Disrupt Human Gut Microbiota Activity And Impact Intestinal Homeostasis As Revealed By In Vitro Systems. Sci Rep. 2018 Jul 20;8(1):11006. doi: 10.1038/s41598-018-29376-9.

  PMID: 30030472 BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Etienne Merlin

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 4, 2022
• Study Start: March 16, 2022
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)