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

Crohn Disease Clinical Trial

— MICROSPA  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983473
• Other study ID #: 2020-A02298-31
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: December 16, 2024

Study information

• Verified date: September 2023
• Source: Central Hospital, Nancy, France
• Contact: Laurent MD PEYRIN-BIROULET, PhD
• Phone: 0383153661
• Email: peyrinbiroulet[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 16, 2024
• Est. primary completion date: November 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

Other:
• Microbiota Sequencing
virome, bacteriome, fungome NGS sequencing

Locations

Country	Name	City	State
France	Central Hospital	Nancy	Lorraine
France	Saint Antoine Hospital	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Centre Hospitalier Régional Metz-Thionville, Saint Antoine University Hospital, University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alpha and Beta diversity of Fecal bacteriome	Alpha (number of species) and Beta diversity (distribution of species)	+ 6 months
Primary	Alpha and Beta diversity of Fecal fungome	Alpha (number of species) and Beta diversity (distribution of species)	+ 6 months
Primary	Alpha and Beta diversity of Fecal virome	Alpha (number of species) and Beta diversity (distribution of species)	+ 6 months