Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.
Recruiting · NCT03983473 · Interventional (participants receive a specific treatment) · Lead sponsor: Central Hospital, Nancy, France
View the official record on ClinicalTrials.gov →Interventions studied
Microbiota Sequencing
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed.
- Saint Antoine Hospital - Paris, France
- Central Hospital - Nancy, Lorraine, France