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

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03983473
Acronym
MICROSPA
Enrollment
240
Registered
2019-06-12
Start date
2021-11-16
Completion date
2027-12-16
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Spondyloarthritis

Brief 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

Interventions

virome, bacteriome, fungome NGS sequencing

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alpha and Beta diversity of Fecal bacteriome+ 6 monthsAlpha (number of species) and Beta diversity (distribution of species)
Alpha and Beta diversity of Fecal fungome+ 6 monthsAlpha (number of species) and Beta diversity (distribution of species)
Alpha and Beta diversity of Fecal virome+ 6 monthsAlpha (number of species) and Beta diversity (distribution of species)

Countries

France

Contacts

CONTACTLaurent MD PEYRIN-BIROULET, PhD
peyrinbiroulet@gmail.com0383153661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026