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NCT Number: NCT03983473

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Hospital, Nancy, Lorraine, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbiota Sequencing

Other

virome, bacteriome, fungome NGS sequencing

Primary outcomes

  1. Alpha and Beta diversity of Fecal bacteriome

    Time frame: + 6 months

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

  2. Alpha and Beta diversity of Fecal fungome

    Time frame: + 6 months

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

  3. Alpha and Beta diversity of Fecal virome

    Time frame: + 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent MD PEYRIN-BIROULET, PhD

CONTACT

[email protected]

0383153661

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Centre Hospitalier Régional Metz-Thionville
  • Saint Antoine University Hospital
  • University Hospital, Strasbourg, France

Registry information

Official study 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.

Acronym: MICROSPA

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2019
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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