Crohn's Disease Clinical Trial
Official title:
Evidence 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.
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.
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.
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