Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. (MICROSPA)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Spondyloarthritis; Crohn Disease

Treatments: Other: Microbiota Sequencing

Study type: Interventional

Funder types: Other

Identifiers

NCT03983473

2020-A02298-31

Details and patient eligibility

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

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

Crohn's disease

Other group

Description:

Patients suffering from established Crohn 's disease without spondyloarthritis

Treatment:

Other: Microbiota Sequencing

Spondyloarthritis

Other group

Description:

Patients with established spondyloarthritis without Crohn 's disease

Treatment:

Other: Microbiota Sequencing

Crohn + spondyloarthritis

Other group

Description:

Patients suffering from both spondyloarthritis and Crohn 's disease

Treatment:

Other: Microbiota Sequencing

Healthy controls

Other group

Description:

Patients without spondyloarthritis and Crohn 's disease

Treatment:

Other: Microbiota Sequencing