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

Primary Purpose

Crohn Disease, Spondyloarthritis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Microbiota Sequencing
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Central HospitalRecruiting
  • Saint Antoine HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Crohn's disease

Spondyloarthritis

Crohn + spondyloarthritis

Healthy controls

Arm Description

Patients suffering from established Crohn 's disease without spondyloarthritis

Patients with established spondyloarthritis without Crohn 's disease

Patients suffering from both spondyloarthritis and Crohn 's disease

Patients without spondyloarthritis and Crohn 's disease

Outcomes

Primary Outcome Measures

Alpha and Beta diversity of Fecal bacteriome
Alpha (number of species) and Beta diversity (distribution of species)
Alpha and Beta diversity of Fecal fungome
Alpha (number of species) and Beta diversity (distribution of species)
Alpha and Beta diversity of Fecal virome
Alpha (number of species) and Beta diversity (distribution of species)

Secondary Outcome Measures

Full Information

First Posted
May 22, 2019
Last Updated
September 19, 2023
Sponsor
Central Hospital, Nancy, France
Collaborators
Centre Hospitalier Régional Metz-Thionville, University Hospital, Strasbourg, France, Saint Antoine University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03983473
Brief Title
Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.
Acronym
MICROSPA
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
November 4, 2024 (Anticipated)
Study Completion Date
December 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
Centre Hospitalier Régional Metz-Thionville, University Hospital, Strasbourg, France, Saint Antoine University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Spondyloarthritis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crohn's disease
Arm Type
Other
Arm Description
Patients suffering from established Crohn 's disease without spondyloarthritis
Arm Title
Spondyloarthritis
Arm Type
Other
Arm Description
Patients with established spondyloarthritis without Crohn 's disease
Arm Title
Crohn + spondyloarthritis
Arm Type
Other
Arm Description
Patients suffering from both spondyloarthritis and Crohn 's disease
Arm Title
Healthy controls
Arm Type
Other
Arm Description
Patients without spondyloarthritis and Crohn 's disease
Intervention Type
Other
Intervention Name(s)
Microbiota Sequencing
Intervention Description
virome, bacteriome, fungome NGS sequencing
Primary Outcome Measure Information:
Title
Alpha and Beta diversity of Fecal bacteriome
Description
Alpha (number of species) and Beta diversity (distribution of species)
Time Frame
+ 6 months
Title
Alpha and Beta diversity of Fecal fungome
Description
Alpha (number of species) and Beta diversity (distribution of species)
Time Frame
+ 6 months
Title
Alpha and Beta diversity of Fecal virome
Description
Alpha (number of species) and Beta diversity (distribution of species)
Time Frame
+ 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent MD PEYRIN-BIROULET, PhD
Phone
0383153661
Email
peyrinbiroulet@gmail.com
Facility Information:
Facility Name
Central Hospital
City
Nancy
State/Province
Lorraine
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent MD PEYRIN-BIROULET, PhD
Facility Name
Saint Antoine Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry SOKOL, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jérémie SELLAM, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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