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

Crohn Disease Clinical Trial

— FLORACROHN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03072836
• Other study ID #: 2016-A01720-51
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: December 15, 2020

Study information

• Verified date: January 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Spondylarthritis
• Spondyloarthritis

Intervention

Other:
• analysing microbiota
16SRNA gene sequencing of feces

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota analysis	16SRNA gene sequencing	6 months after last patient inclusion