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

NCT ID: NCT03983473

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2026-12-16

Brief Summary

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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

Detailed Description

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Conditions

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Crohn Disease Spondyloarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Crohn's disease

Patients suffering from established Crohn 's disease without spondyloarthritis

Group Type OTHER

Microbiota Sequencing

Intervention Type OTHER

virome, bacteriome, fungome NGS sequencing

Spondyloarthritis

Patients with established spondyloarthritis without Crohn 's disease

Group Type OTHER

Microbiota Sequencing

Intervention Type OTHER

virome, bacteriome, fungome NGS sequencing

Crohn + spondyloarthritis

Patients suffering from both spondyloarthritis and Crohn 's disease

Group Type OTHER

Microbiota Sequencing

Intervention Type OTHER

virome, bacteriome, fungome NGS sequencing

Healthy controls

Patients without spondyloarthritis and Crohn 's disease

Group Type OTHER

Microbiota Sequencing

Intervention Type OTHER

virome, bacteriome, fungome NGS sequencing

Interventions

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Microbiota Sequencing

virome, bacteriome, fungome NGS sequencing

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role collaborator

Saint Antoine University Hospital

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Dr Laurent PEYRIN-BIROULET

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Central Hospital

Nancy, Lorraine, France

Site Status RECRUITING

Saint Antoine Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laurent MD PEYRIN-BIROULET, PhD

Role: CONTACT

0383153661

Facility Contacts

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Laurent MD PEYRIN-BIROULET, PhD

Role: primary

Harry SOKOL, MD, PhD

Role: primary

Jérémie SELLAM, MD, PhD

Role: backup

Other Identifiers

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2020-A02298-31

Identifier Type: -

Identifier Source: org_study_id

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