Completed

MAGICEvidence of Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease: Family Studies and Relations With a Particular Genetic Profile and Serological. Comparison of Affected Individuals, Their Siblings and Healthy Controls.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
DNA Samples
Who is being recruted

Crohn Disease+9

+ Digestive System Diseases

+ Disease Susceptibility

From 8 to 50 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Family-Based

Studying health outcomes within families in order to identify genetic or familial contributions to disease.
Observational
Study Start: October 2013
See protocol details

Summary

Principal SponsorUniversity Hospital, Lille
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 3, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleEvidence of Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease: Family Studies and Relations With a Particular Genetic Profile and Serological. Comparison of Affected Individuals, Their Siblings and Healthy Controls.
NCT02826330
Principal SponsorUniversity Hospital, Lille
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Family-Based

These studies involve members of the same family to explore how genetics and shared environments may contribute to a disease. They help researchers pinpoint inherited risk factors.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 8 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Crohn DiseaseDigestive System DiseasesDisease SusceptibilityGastroenteritisGastrointestinal DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInflammatory Bowel DiseasesGenetic Predisposition to DiseaseDisease AttributesDysbiosis

Criteria

4 inclusion criteria required to participate
Having at least one first degree health relative

Specific clinical questionnaire and dosing fecal calprotectin to ensure the absence of inflammatory pathology

Patient > 18 years old

OK to participate in the project

6 exclusion criteria prevent from participating
Intestinal resection

Pregnant or breastfeeding woman

Subject under guardianship

Subject does not speak French

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

Amiens University & Hospital

Amiens, FranceOpen Amiens University & Hospital in Google Maps
Suspended

cLERMONT fERRAND University Hospital

Clermont-Ferrand, France
Suspended

APHP Kremlin Bicêtre

Le Kremlin-Bicêtre, France
Suspended

CHRU,Hôpital Jeanne de Flandres

Lille, France
Completed10 Study Centers