Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT05176795
Status:
RECRUITING
Last Update Posted:
2022-12-22
First Post:
2021-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Host-microbiota-environment Interactions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut microbiota composition', 'timeFrame': 'Day 1', 'description': 'Variation between cases and controls in gut microbiota composition (determination of the gut microbiota composition by 16S metagenomic)'}, {'measure': 'Gut microbiota composition', 'timeFrame': '12 months', 'description': 'Variation between cases and controls in gut microbiota composition (determination of the gut microbiota composition by 16S metagenomic)'}], 'secondaryOutcomes': [{'measure': 'Composition of the fecal volatolome', 'timeFrame': 'Day 1', 'description': 'The volatile compounds in the samples will be analyzed via solid-phase microextraction (SPME) coupled with gas chromatography-mass spectrometry (GC-MS)'}, {'measure': 'Variation in gut microbiota following initiation of therapy in patients newly diagnosed with JIA, IBD or T1DM.', 'timeFrame': 'Day 1, 2 months, 12 months', 'description': 'Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA'}, {'measure': 'Tryptasemia', 'timeFrame': 'Day 1, 2 months, 12 months', 'description': 'Variation in plasma tryptase levels during the first year of the disease'}, {'measure': 'Fecal contamination with nanoparticles', 'timeFrame': 'Day 1', 'description': 'measurement of titane and silicia levels in stool sample'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiota', 'environmental factors', 'food contaminants'], 'conditions': ['Juvenile Idiopathic Arthritis', 'Diabetes type1', 'Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '20400104', 'type': 'BACKGROUND', '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.'}, {'pmid': '28991267', 'type': 'BACKGROUND', '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.'}, {'pmid': '27833598', 'type': 'BACKGROUND', '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.'}, {'pmid': '30030472', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.\n\nOn 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.', 'detailedDescription': 'Exploratory pathophysiology monocentric study including an initial case-control study, followed by a cohort for cases.\n\nControls will be siblings of cases with longitudinal follow-up.\n\nStool samples will be collected simultaneously from the child with JIA, T1DM or IBD (case) and his/her sibling(s) (control):\n\n* at the time of diagnosis\n* two months after diagnosis (for children with inflammatory disease only)\n* one year after diagnosis (cases and controls)\n\nTryptase 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants include patient-sibling pairs meeting the inclusion criteria (30 children newly diagnosed with JIA, IBD or T1DM and 30 siblings).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCASE:\n\n\\- Newly diagnosed with JIA, IBD or T1DM\n\nCONTROL:\n\n\\- Brother/sister of child with pediatric onset inflammatory disease (same age category - same environment: diet, living environment)\n\nExclusion Criteria (case and control):\n\n* Child with antibiotic treatment in the 4 weeks preceding the stool sample\n* Recent digestive infectious disease (bacterial, viral, parasitic) (end of episode \\< 7 days)\n\nExclusion Criteria (control): children with autoimmune or inflammatory disease'}, 'identificationModule': {'nctId': 'NCT05176795', 'acronym': 'MIP-1', 'briefTitle': 'Host-microbiota-environment Interactions', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Study of the Determinants of Pediatric Onset Inflammatory Diseases: Host-microbiota-environment Interactions', 'orgStudyIdInfo': {'id': 'RNI 2021 MERLIN'}, 'secondaryIdInfos': [{'id': '2021-AO1006-35', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'Child under 10 years old newly diagnosed with JIA, IBD or T1DM', 'interventionNames': ['Other: Stool sample']}, {'label': 'Active Comparator: Healthy control', 'description': 'Brother/sister of child with pediatric onset inflammatory disease (same age category - same environment: food, living space)', 'interventionNames': ['Other: Stool sample']}], 'interventions': [{'name': 'Stool sample', 'type': 'OTHER', 'description': 'Comparaison of the gut microbiota composition', 'armGroupLabels': ['Active Comparator: Healthy control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne Merlin', 'role': 'CONTACT', 'email': 'e_merlin@chu-clermontferrand.fr', 'phone': '04-73-75-00-15'}, {'name': 'Etienne Merlin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '+33473754963'}], 'overallOfficials': [{'name': 'Etienne Merlin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}