NCT03983473 Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.
| NCT ID | NCT03983473 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Hospital, Nancy, France |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2021-11-16 |
| Primary Completion | 2027-11-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2021-11-16 with a primary completion date of 2027-11-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03983473 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03983473 currently recruiting?
Yes, NCT03983473 is actively recruiting participants. Contact the research team at peyrinbiroulet@gmail.com for enrollment information.
Where is the NCT03983473 trial being conducted?
This trial is being conducted at Nancy, France, Paris, France.
Who is sponsoring the NCT03983473 clinical trial?
NCT03983473 is sponsored by Central Hospital, Nancy, France. The trial plans to enroll 240 participants.