Host-microbiota-environment Interactions (MIP-1)

December 21, 2022 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • CHU de Clermont-Ferrand
        • Principal Investigator:
          • Etienne MERLIN
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota composition
Time Frame: Day 1
Variation between cases and controls in gut microbiota composition (determination of the gut microbiota composition by 16S metagenomic)
Day 1
Gut microbiota composition
Time Frame: 12 months
Variation between cases and controls in gut microbiota composition (determination of the gut microbiota composition by 16S metagenomic)
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Investigators

  • Principal Investigator: Etienne MERLIN, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2022

Primary Completion (Anticipated)

March 1, 2026

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2021 MERLIN
  • 2021-AO1006-35 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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