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Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis (FLORACROHN)

Primary Purpose

Crohn Disease, Spondyloarthritis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
analysing microbiota
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.

    • Patients with Crohn's disease (CT patients) diagnosed according to clinical, biological, radiological, endoscopic and / or histological criteria for 3 months. With diagnosis of spondyloarthritis exclusion on modified ASAS and / or New York criteria.
    • Patients with axial spondyloarthritis (SpA patients) diagnosed according to the modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease.
  • Patient with the capacity to give free and informed consent.

Exclusion Criteria:

Antecedent of colonic resection

  • Antibiotic or colonic colonoscopy preparation in the 8 weeks prior to stool collection (against temporary indication = collection possible before colic preparation or on the first saddle after the start of the colic preparation).
  • Ostomy at time of collection
  • BMI> 30
  • extreme diet
  • unbalanced diabetes
  • Patient under guardianship, under curatorship or under safeguard of justice

Sites / Locations

  • CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CD alone

SPA alone

CD + SPA

Arm Description

Outcomes

Primary Outcome Measures

Microbiota analysis
16SRNA gene sequencing

Secondary Outcome Measures

Full Information

First Posted
March 2, 2017
Last Updated
January 22, 2020
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03072836
Brief Title
Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis
Acronym
FLORACROHN
Official Title
Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
May 15, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

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 FLORACROHN project aims to compare gut microbiota 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. Fecal microbiota will be determined by 16SRNA gene 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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD alone
Arm Type
Experimental
Arm Title
SPA alone
Arm Type
Experimental
Arm Title
CD + SPA
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
analysing microbiota
Intervention Description
16SRNA gene sequencing of feces
Primary Outcome Measure Information:
Title
Microbiota analysis
Description
16SRNA gene sequencing
Time Frame
6 months after last patient inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Crohn's disease and axial spondyloarthritis according to the criteria below. Patients with Crohn's disease (CT patients) diagnosed according to clinical, biological, radiological, endoscopic and / or histological criteria for 3 months. With diagnosis of spondyloarthritis exclusion on modified ASAS and / or New York criteria. Patients with axial spondyloarthritis (SpA patients) diagnosed according to the modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease. Patient with the capacity to give free and informed consent. Exclusion Criteria: Antecedent of colonic resection Antibiotic or colonic colonoscopy preparation in the 8 weeks prior to stool collection (against temporary indication = collection possible before colic preparation or on the first saddle after the start of the colic preparation). Ostomy at time of collection BMI> 30 extreme diet unbalanced diabetes Patient under guardianship, under curatorship or under safeguard of justice
Facility Information:
Facility Name
CHRU de Nancy
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent PEYRIN-BIROULET, MD, PHD
Phone
03 83 15 36 61
Email
l.peyrin-biroulet@chu-nancy.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis

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