Juvenile Idiopathic ArthritisMIP-1NCT05176795
Host-microbiota-environment Interactions
An observational study of Juvenile Idiopathic Arthritis and Diabetes type1, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 0 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Diabetes type1, Inflammatory Bowel Diseases
- What is being tested?
- Stool sample
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2022to 12 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The participants include patient-sibling pairs meeting the inclusion criteria (30 children newly diagnosed with JIA, IBD or T1DM and 30 siblings).
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Being tested
- Stool sample
- Keywords
- microbiota, environmental factors, food contaminants
- Medical subject headings
- Arthritis, Juvenile, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sampleOther
Comparaison of the gut microbiota composition
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Child under 10 years old newly diagnosed with JIA, IBD or T1DM Receives: Other: Stool sample | |
| Active Comparator: Healthy control | Brother/sister of child with pediatric onset inflammatory disease (same age category - same environment: food, living space) Receives: Other: Stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition
Variation between cases and controls in gut microbiota composition (determination of the gut microbiota composition by 16S metagenomic)
Measured: Day 1
Gut microbiota composition
Variation between cases and controls in gut microbiota composition (determination of the gut microbiota composition by 16S metagenomic)
Measured: 12 months
Secondary outcomes (4)
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)
Measured: Day 1
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
Measured: Day 1, 2 months, 12 months
Tryptasemia
Variation in plasma tryptase levels during the first year of the disease
Measured: Day 1, 2 months, 12 months
Fecal contamination with nanoparticles
measurement of titane and silicia levels in stool sample
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start16 Mar 2022
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Why it stopped: logistical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
- Investigators
- Etienne Merlin, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176795
- Sponsor's protocol ID
- RNI 2021 MERLIN
- Other IDs
- 2021-AO1006-35
- Acronym
- MIP-1
- Status last verified
- Apr 2026
- First submitted
- 14 Dec 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20400104Rouxel 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.
PubMed 28991267Di 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.
PubMed 27833598Defois 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.
PubMed 30030472
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Determinants of Pediatric Onset Inflammatory Diseases: Host-microbiota-environment Interactions
- ClinicalTrials.gov ID
- NCT05176795
- Acronym / sponsor ID
- MIP-1 / RNI 2021 MERLIN
- Keywords
- microbiota, environmental factors, food contaminants
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: logistical difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Stool sampleChild under 10 years old newly diagnosed with JIA, IBD or T1DM |
| Active Comparator: Healthy control | – | Other: Stool sampleBrother/sister of child with pediatric onset inflammatory disease (same age category - same environment: food, living space) |
Who may qualify
- Ages
- 0 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The participants include patient-sibling pairs meeting the inclusion criteria (30 children newly diagnosed with JIA, IBD or T1DM and 30 siblings).
Key inclusion criteria (4 listed)
- Newly diagnosed with JIA, IBD or T1DM
- Brother/sister of child with pediatric onset inflammatory disease (same age category - same environment: diet, living environment)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool sampleComparaison of the gut microbiota composition | Other | Active Comparator: Healthy control, Experimental |
Primary outcome
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)
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)
4 secondary outcomes
Composition of the fecal volatolome
Time frame: 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
Tryptasemia
Time frame: Day 1, 2 months, 12 months
Fecal contamination with nanoparticles
Time frame: Day 1
Results and safety
The study was stopped early (reason given: logistical difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 20400104Schwiertz 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.
- Background: PubMed 28991267Rouxel 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.
- Background: PubMed 27833598Di 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.
- Background: PubMed 30030472Defois 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne Merlin principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis and Diabetes type1, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: logistical difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota composition (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05176795, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.