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Host-microbiota-environment Interactions

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05176795
Acronym
MIP-1
Enrollment
4
Registered
2022-01-04
Start date
2022-03-16
Completion date
2022-07-12
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes type1, Inflammatory Bowel Diseases, Juvenile Idiopathic Arthritis

Keywords

microbiota, environmental factors, food contaminants

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)

Interventions

OTHERStool sample

Comparaison of the gut microbiota composition

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 10 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiota compositionDay 1Variation between cases and controls in gut microbiota composition (determination of the gut microbiota composition by 16S metagenomic)

Secondary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATOREtienne Merlin

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026