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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03072836
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Central Hospital, Nancy, France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease, Spondyloarthritis
Arms & Interventions

Arms

Experimental: CD alone

Experimental: SPA alone

Experimental: CD + SPA

Interventions

Other: - analysing microbiota

16SRNA gene sequencing of feces

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHRU de Nancy, Vandoeuvre les Nancy, France

Status

Recruiting

Address

CHRU de Nancy

Vandoeuvre les Nancy, , 54511

Site Contact

Laurent PEYRIN-BIROULET, MD, PHD

l.peyrin-biroulet@chu-nancy.fr

03 83 15 36 61

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