Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease

Study Purpose

Transversal multicentric French study on the microbiota in patients with Crohn's disease and their first degree healthy relatives The primary objective is the comparison of microbiota between patients with CD, healthy controls non genetically linked and first degree healthy relatives of patients with CD.

Recruitment Criteria

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

Accepts Healthy Volunteers
Yes

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.

Study Type
Observational [Patient Registry]
Eligible Ages 8 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Patient with Crohn's disease
  • - Patient > 18 years old - Having at least one first degree health relative - OK to participate to the project First degree healthy relatives - specific clinical questionnaire and dosing fecal calprotectin to ensure the absence of inflammatory pathology.
  • - OK to participate to the project

    Exclusion Criteria:

    - Intestinal resection.
  • - Pregnant or breastfeeding woman.
  • - subject under guardianship - subject does not speak French - person unable to speak - taking antibiotics or bowel preparation will push 6 weeks stool specimens, after cessation treatments.

Trial Details

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.

Trial ID:
NCT02826330

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

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.

Phase
N/A

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

Lead Sponsor
University Hospital, Lille

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

Agency Class
Other
Overall Status Recruiting
Countries France

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

Conditions
Crohn's Disease, Genetic Predisposition
Additional Details

Crohn's disease is a chronic inflammatory bowel disease associating flares and remission periods. Its etiology is unknown and there are no specific therapy. CD affects young patients and has a major impact on quality of life. There are few population-based studies and there are about 2.5 million affected patients in Europe and North America. From data from EPIMAD Registry the number of affected patients in France should be 200 000. The Crohn's disease pathogenesis is bad known; It coul be the results of the activation of the gastro-intestinal immune system toward gut microbiota in genetically susceptible hosts. In CD patients there is an important ecologic modification of the flora with an excess of Bacteroidetes and Proteobacteria and a decrease of anti inflammatory bacteria (Firmicutes). In ileum of CD patients a specific E Coli (adherent and invasive E Colo) is found in two thirds of cases.The presence of this AIEC seems to be associated to the variant NOD2 (results from our team in multiplex families). In a family with at least 1 patient with CD, the healthy first degree relatives present a high risk (* 10) to also develop a CD. The primary objective is the comparison of microbiota between patients with CD, healthy controls non genetically linked and first degree healthy relatives of patients with CD. The first endpoint is the Lachnospiraceae rates in each group. The secondary objectives are : 1. the search for an association between bacterial dysbiosis and different genetic backgrounds in patients with CD, their first degree healthy relatives and controls. 2. the quantification of potential invasive bacteria with invasive properties (E. coli including adherent-invasive E. coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular) and their association with genetic and serological profiles in patients with CD, their healthy relatives and control subjects. 3. a study of environmental risk factors using a questionnaire to be submitted to CD patients, their healthy relatives and control subjects.

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

Amiens University & Hospital, Amiens, France

Status

Not yet recruiting

Address

Amiens University & Hospital

Amiens, , 80000

Site Contact

Mathurin Fumery, MD

cLERMONT fERRAND University Hospital, Clermont FERRAND, France

Status

Recruiting

Address

cLERMONT fERRAND University Hospital

Clermont FERRAND, , 63000

Site Contact

gILLES Bommelaer, MD,PhD

APHP Kremlin Bicêtre, Le Kremlin Bicêtre, France

Status

Recruiting

Address

APHP Kremlin Bicêtre

Le Kremlin Bicêtre, ,

Site Contact

Franck Carbonnel, MD, PhD

CHRU,Hôpital Jeanne de Flandres, Lille, France

Status

Recruiting

Address

CHRU,Hôpital Jeanne de Flandres

Lille, ,

Hôpital Claude Huriez, CHRU, Lille, France

Status

Recruiting

Address

Hôpital Claude Huriez, CHRU

Lille, ,

Nancy University Hospital, Nancy, France

Status

Not yet recruiting

Address

Nancy University Hospital

Nancy, , 54000

Site Contact

Laurent Peyrin-Biroulet, MD, PhD

Aphp Necker, Paris, France

Status

Recruiting

Address

Aphp Necker

Paris, , 75000

Site Contact

Franck Ruemmele, MD,PhD

APHP Robert Debré, Paris, France

Status

Recruiting

Address

APHP Robert Debré

Paris, , 75000

Site Contact

Jean-Pierre HUGOT, MD,PhD

Aphp St Antoine, Paris, France

Status

Recruiting

Address

Aphp St Antoine

Paris, , 75000

Site Contact

Philippe SEKSIK, MD,PhD

Rouen University Hospital, Rouen, France

Status

Recruiting

Address

Rouen University Hospital

Rouen, , 76000

Site Contact

Guillaume Savoye, MD, PhD

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