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RecruitingNCT03983473MICROSPAUpdated Jun 18, 2026

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

An interventional study of Microbiota Sequencing in Crohn Disease and Spondyloarthritis, sponsored by Central Hospital, Nancy, France. Recruiting at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Nov 2021; still recruiting 4 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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

02

Conditions studied

  • Crohn Disease
  • Spondyloarthritis
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 240 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Other
    Crohn's disease

    Patients suffering from established Crohn 's disease without spondyloarthritis

    Other: Microbiota Sequencing

  • Other
    Spondyloarthritis

    Patients with established spondyloarthritis without Crohn 's disease

    Other: Microbiota Sequencing

  • Other
    Crohn + spondyloarthritis

    Patients suffering from both spondyloarthritis and Crohn 's disease

    Other: Microbiota Sequencing

  • Other
    Healthy controls

    Patients without spondyloarthritis and Crohn 's disease

    Other: Microbiota Sequencing

Interventions

  • OtherMicrobiota Sequencing

    virome, bacteriome, fungome NGS sequencing

06

What researchers measure

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

07

Study locations

2 of 2 sites recruiting
  • Central Hospital
    Nancy, Lorraine 54500, France
    • Laurent MD PEYRIN-BIROULET, PhD · Contact
    Recruiting
  • Saint Antoine Hospital
    Paris, 75012, France
    • Harry SOKOL, MD, PhD · Contact
    • Jérémie SELLAM, MD, PhD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03983473
Lead sponsor
Central Hospital, Nancy, France
Collaborators
Centre Hospitalier Régional Metz-Thionville, University Hospital, Strasbourg, France, Saint Antoine University Hospital
Responsible party
FERRY Marine (Doctor, Central Hospital, Nancy, France) — Principal investigator
First posted
Jun 12, 2019
Start date
Nov 16, 2021
Primary completion
Nov 4, 2027 (estimated)
Completion
Dec 16, 2027 (estimated)
Last update
Jun 18, 2026

Study contacts

Laurent MD PEYRIN-BIROULET, PhD
Contact
peyrinbiroulet@gmail.com
0383153661

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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