Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.
MICROSPA
1 other identifier
interventional
240
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2019
CompletedStudy Start
First participant enrolled
November 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 16, 2026
February 3, 2026
January 1, 2026
5 years
May 22, 2019
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (4)
Crohn's disease
OTHERPatients suffering from established Crohn 's disease without spondyloarthritis
Spondyloarthritis
OTHERPatients with established spondyloarthritis without Crohn 's disease
Crohn + spondyloarthritis
OTHERPatients suffering from both spondyloarthritis and Crohn 's disease
Healthy controls
OTHERPatients without spondyloarthritis and Crohn 's disease
Interventions
virome, bacteriome, fungome NGS sequencing
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- Patients will be recruited according to 3 groups:
- Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
- Patient with the ability to give free and express informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Central Hospital, Nancy, Francelead
- Centre Hospitalier Régional Metz-Thionvillecollaborator
- University Hospital, Strasbourg, Francecollaborator
- Saint Antoine University Hospitalcollaborator
Study Sites (2)
Central Hospital
Nancy, Lorraine, 54500, France
Saint Antoine Hospital
Paris, 75012, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
May 22, 2019
First Posted
June 12, 2019
Study Start
November 16, 2021
Primary Completion (Estimated)
November 4, 2026
Study Completion (Estimated)
December 16, 2026
Last Updated
February 3, 2026
Record last verified: 2026-01