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

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.

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

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Spondyloarthritis
• Intervention / Treatment: Other: Microbiota Sequencing

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurent MD PEYRIN-BIROULET, PhD; Phone Number: 0383153661; Email: peyrinbiroulet@gmail.com

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Saint Antoine Hospital
    • Contact: Harry SOKOL, MD, PhD
    • Contact: Jérémie SELLAM, MD, PhD
  • Lorraine
    • Nancy, Lorraine, France, 54500
      • Recruiting
      • Central Hospital
      • Contact: Laurent MD PEYRIN-BIROULET, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Crohn's disease; Patients suffering from established Crohn 's disease without spondyloarthritis	Other: Microbiota Sequencing; virome, bacteriome, fungome NGS sequencing
Other: Spondyloarthritis; Patients with established spondyloarthritis without Crohn 's disease	Other: Microbiota Sequencing; virome, bacteriome, fungome NGS sequencing
Other: Crohn + spondyloarthritis; Patients suffering from both spondyloarthritis and Crohn 's disease	Other: Microbiota Sequencing; virome, bacteriome, fungome NGS sequencing
Other: Healthy controls; Patients without spondyloarthritis and Crohn 's disease	Other: Microbiota Sequencing; virome, bacteriome, fungome NGS sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alpha and Beta diversity of Fecal bacteriome	Alpha (number of species) and Beta diversity (distribution of species)	+ 6 months
Alpha and Beta diversity of Fecal fungome	Alpha (number of species) and Beta diversity (distribution of species)	+ 6 months
Alpha and Beta diversity of Fecal virome	Alpha (number of species) and Beta diversity (distribution of species)	+ 6 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: University Hospital, Strasbourg, France; Saint Antoine University Hospital; Centre Hospitalier Régional Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Estimated): November 4, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Joint Diseases; Musculoskeletal Diseases; Gastroenteritis; Arthritis; Intestinal Diseases; Spinal Diseases; Bone Diseases; Inflammatory Bowel Diseases; Bone Diseases, Infectious; Crohn Disease; Spondylitis; Spondylarthritis
• Other Study ID Numbers: 2020-A02298-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No