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

NCT ID: NCT03072836

Last Updated: 2020-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2020-12-15

Brief Summary

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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

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Conditions

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Crohn Disease Spondyloarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CD alone

Group Type EXPERIMENTAL

analysing microbiota

Intervention Type OTHER

16SRNA gene sequencing of feces

SPA alone

Group Type EXPERIMENTAL

analysing microbiota

Intervention Type OTHER

16SRNA gene sequencing of feces

CD + SPA

Group Type EXPERIMENTAL

analysing microbiota

Intervention Type OTHER

16SRNA gene sequencing of feces

Interventions

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analysing microbiota

16SRNA gene sequencing of feces

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Pr Laurent PEYRIN BIROULET

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHRU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Laurent PEYRIN-BIROULET, MD, PHD

Role: primary

03 83 15 36 61

Other Identifiers

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2016-A01720-51

Identifier Type: -

Identifier Source: org_study_id

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