Crohn Disease Clinical Trial
— MICROSPAOfficial title:
Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. Identification de Biomarqueurs de SPondylArthrite Chez Les Patients Atteints de Maladie de CROhn présents Dans le MICrobiote fécal.
The MICROSPA project aims to compare gut microbiota, serum cytokines, and PBMC of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. One group of healthy controls will be analysed as a comparator. Fecal microbiota will be determined by bacteriome, virome and fungome NGS sequencing
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 16, 2024 |
Est. primary completion date | November 4, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years. - Patients will be recruited according to 3 groups: - Patients with Crohn's disease and axial spondyloarthritis according to the criteria below. - Patients with Crohn's disease (MC patients) with a diagnosis established according to clinical, biological criteria, radiological, endoscopic and / or histological studies for 3 months. With diagnosis of exclusion of a spondyloarthritis on criteria ASAS and / or New York modified. - Patients with axial spondyloarthritis (SpA patients) with a diagnosis based on modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease. - Patient with the ability to give free and express informed consent. Exclusion Criteria: - History of colonic resection - Taking antibiotics or colon preparation for colonoscopy within 8 weeks before stool collection (Temporary contraindication = removal possible before colic or first bowel preparation after the start of colonic preparation). - Ostomy at the time of sampling - BMI> 30 - extreme diet - unbalanced diabetes - Pregnant woman - Patient under guardianship, under curatorship or under the protection of justice Contacts/Locations Central Contact |
Country | Name | City | State |
---|---|---|---|
France | Central Hospital | Nancy | Lorraine |
France | Saint Antoine Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France | Centre Hospitalier Régional Metz-Thionville, Saint Antoine University Hospital, University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alpha and Beta diversity of Fecal bacteriome | Alpha (number of species) and Beta diversity (distribution of species) | + 6 months | |
Primary | Alpha and Beta diversity of Fecal fungome | Alpha (number of species) and Beta diversity (distribution of species) | + 6 months | |
Primary | Alpha and Beta diversity of Fecal virome | Alpha (number of species) and Beta diversity (distribution of species) | + 6 months |
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