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

ConditionsCrohn DiseaseSpondyloarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years.

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Microbiota Sequencing

    Other intervention

    virome, bacteriome, fungome NGS sequencing

Treatment groups

240 Participants
are divided into 4 treatment groups
Group A: Crohn's diseaseOther 1 intervention
Group B: SpondyloarthritisOther 1 intervention
Group C: Crohn + spondyloarthritisOther 1 intervention
Group D: Healthy controlsOther 1 intervention

Trial outcomes

Primary outcomes

1

Alpha and Beta diversity of Fecal bacteriome

Alpha (number of species) and Beta diversity (distribution of species)

Time frame
+ 6 months
2

Alpha and Beta diversity of Fecal fungome

Alpha (number of species) and Beta diversity (distribution of species)

Time frame
+ 6 months
3

Alpha and Beta diversity of Fecal virome

Alpha (number of species) and Beta diversity (distribution of species)

Time frame
+ 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Central Hospital, Nancy, France

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Collaborator

University Hospital, Strasbourg, France

Collaborator

Saint Antoine University Hospital

Collaborator

Source ClinicalTrials.gov
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