Identifying gut bacteria linked to spondyloarthritis in Crohn's disease patients
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.
This study is trying to find out if certain gut bacteria are linked to spondyloarthritis in people who have Crohn's disease by comparing them to healthy individuals and those with just one of the conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 2 sites (Nancy, Lorraine and 1 other locations) |
| Trial ID | NCT03983473 on ClinicalTrials.gov |
What this trial studies
The MICROSPA project aims to analyze the gut microbiota, serum cytokines, and peripheral blood mononuclear cells (PBMC) in patients with Crohn's disease (CD) and/or spondyloarthritis (SpA). It will compare three groups: those with CD alone, those with SpA alone, and those with both conditions, alongside a healthy control group. The study will utilize next-generation sequencing (NGS) to determine the composition of fecal microbiota, including bacteriome, virome, and fungome, to identify potential biomarkers associated with these diseases.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of Crohn's disease, spondyloarthritis, or both.
Not a fit: Patients with a history of colonic resection or those currently taking antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of microbiota biomarkers that may improve diagnosis and treatment strategies for patients with Crohn's disease and spondyloarthritis.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown promise in identifying microbiota-related biomarkers in other inflammatory conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nancy, Lorraine and 1 other locations
- Central Hospital — Nancy, Lorraine, France (Recruiting)
- Saint Antoine Hospital — Paris, France (Recruiting)
Study contacts
- Study coordinator: Laurent MD PEYRIN-BIROULET, PhD
- Email: peyrinbiroulet@gmail.com
- Phone: 0383153661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.