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

Not Applicable

• Conditions: Spondyloarthritis; Crohn Disease
• Interventions: Other: analysing microbiota

• Registration Number: NCT03072836
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-02
• Study Start: 2017-03-06
• Study First Posted: 2017-03-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23
• Primary Completion: 2020-05-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPA alone	analysing microbiota	-
CD + SPA	analysing microbiota	-
CD alone	analysing microbiota	-

Primary Outcome Measures

Name	Time	Method
Microbiota analysis	6 months after last patient inclusion	16SRNA gene sequencing

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Vandoeuvre les Nancy, France