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

Not Applicable

Recruiting

• Conditions: Crohn Disease; Spondyloarthritis
• Interventions: Other: Microbiota Sequencing

• Registration Number: NCT03983473
• Lead Sponsor: Central Hospital, Nancy, France

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-12
• Study Start: 2021-11-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-11-04
• Study Completion: 2025-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crohn's disease	Microbiota Sequencing	Patients suffering from established Crohn 's disease without spondyloarthritis
Spondyloarthritis	Microbiota Sequencing	Patients with established spondyloarthritis without Crohn 's disease
Healthy controls	Microbiota Sequencing	Patients without spondyloarthritis and Crohn 's disease
Crohn + spondyloarthritis	Microbiota Sequencing	Patients suffering from both spondyloarthritis and Crohn 's disease

Primary Outcome Measures

Name	Time	Method
Alpha and Beta diversity of Fecal fungome	+ 6 months	Alpha (number of species) and Beta diversity (distribution of species)
Alpha and Beta diversity of Fecal bacteriome	+ 6 months	Alpha (number of species) and Beta diversity (distribution of species)
Alpha and Beta diversity of Fecal virome	+ 6 months	Alpha (number of species) and Beta diversity (distribution of species)

Trial Locations

Locations (2)

Central Hospital; 🇫🇷 Nancy, Lorraine, France

Saint Antoine Hospital; 🇫🇷 Paris, France