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Recruiting NCT03983473

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

No phase Interventional Crohn Disease Spondyloarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Microbiota Sequencing.
Who it may be relevant to
Registry conditions: Crohn Disease, Spondyloarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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

Interventions

  • Other Microbiota Sequencing
    virome, bacteriome, fungome NGS sequencing

Primary outcome measures

  • Alpha and Beta diversity of Fecal bacteriome [Time frame: + 6 months]
  • Alpha and Beta diversity of Fecal fungome [Time frame: + 6 months]
  • Alpha and Beta diversity of Fecal virome [Time frame: + 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

France · 2 centers
  • Central Hospital — Nancy
  • Saint Antoine Hospital — Paris

Identifiers

NCT: NCT03983473 · 2020-A02298-31

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗