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

C

Central Hospital, Nancy, France

Status

Unknown

Conditions

Spondyloarthritis
Crohn Disease

Treatments

Other: analysing microbiota

Study type

Interventional

Funder types

Other

Identifiers

NCT03072836
2016-A01720-51

Details and patient eligibility

About

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.

Enrollment

108 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

108 participants in 3 patient groups

CD alone
Experimental group
Treatment:
Other: analysing microbiota
SPA alone
Experimental group
Treatment:
Other: analysing microbiota
CD + SPA
Experimental group
Treatment:
Other: analysing microbiota

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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