Ireland
--:--IST
Recruiting Not applicable

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

NCT03983473 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-11-16
Last updated
2026-06-18

Condition(s) studied

Crohn DiseaseSpondyloarthritis

Investigational drug(s) / intervention(s)

Microbiota Sequencing

Microbiota Sequencing: virome, bacteriome, fungome NGS sequencing

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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 fungome — + 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 sites (2)

FacilityCityRegionStatus
Central Hospital Nancy Lorraine Recruiting
Saint Antoine Hospital Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03983473 on ClinicalTrials.gov ↗ ← All trials in France