Host-microbiota-environment Interactions

Inflammatory Bowel Diseases Clinical Trial

— MIP-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176795
• Other study ID #: RNI 2021 MERLIN
• Secondary ID: 2021-AO1006-35
• Status: Recruiting
• Start date: March 16, 2022
• Est. completion date: September 2026

Study information

• Verified date: December 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Juvenile
• Diabetes Mellitus, Type 1
• Diabetes type1
• Inflammatory Bowel Diseases
• Juvenile Idiopathic Arthritis

Intervention

Other:
• Stool sample
Comparaison of the gut microbiota composition

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Erratum In: Nat Immunol. 2018 Jun 7;: — View Citation

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. — View Citation

Outcome

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