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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00802-41 | Other Identifier | ID-RCB number, ANSM |
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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| case Crohn disease | 60 cases with Crohn's Disease |
| |
| first relative healthy | 2 healthy relatives per CD case (total 120) |
| |
| controls | 60 controls matched on gender and age with CD cases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biomarkers | Other | fecal microbiota analysis antibodies in serum and saliva DNA polymorphisms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Lachnospiraceae bacteria in stools within 3 groups | After extraction DNA, microbiota will be studied via study of ribosomal DNA 16S using quantitative PCR and pyroséquençage | 1 YEAR |
| Measure | Description | Time Frame |
|---|---|---|
| Number of bacteria Firmicutes phylum (including Faecalibacterium prausnitzii and Clostridium Leptum) in stools within 3 groups | After extraction DNA, microbiota will be studied via study of ribosomal DNA 16S using quantitative PCR and pyroséquençage | 1 year |
| Define different genetic and serologic backgrounds within 3 groups |
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Inclusion Criteria:
Patient with Crohn's disease
First degree healthy relatives
Exclusion Criteria:
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Transversal multicentric French study on the microbiota in patients with Crohn's disease (n=60) and their first degree healthy relatives (n=120) and controls (n=60).
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| Name | Affiliation | Role |
|---|---|---|
| Corinne Gower-Rousseau, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens University & Hospital | Amiens | 80000 | France | |||
| cLERMONT fERRAND University Hospital |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D020022 | Genetic Predisposition to Disease |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015415 | Biomarkers |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
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Blood, saliva, stools
|
Genetic analysis will include 380 genetic variants génétiques that will be genotyped including classic variants involved in CD: variants or mutations of NOD2, NOD1, IL23R, ATG16L1, DGL5, TNF, IL6, NFKB1... genes. Serological analysis will included anti-OmpC, anti-I2 and ASCA auto antibodies. |
| 1 year |
| Quantify of bacteria with invasive properties (including AIEC) within 3 groups | Amplify bacterial DNA of Salmonella Typhi (amplification of ITS area specific of ARNr 16S-23S gene. For AIEC, using of qPCR methods based on chuA and yjaA genes. | 1 year |
| Study of environmental risk factors within 3 groups | Specific questionnaire on environmental risk factors including vaccination, antibiotic use, ionfections, Home facilities and Diet befor the CD diagnosis | 1 year |
| Clermont-Ferrand |
| 63000 |
| France |
| APHP Kremlin Bicêtre | Le Kremlin-Bicêtre | France |
| CHRU,Hôpital Jeanne de Flandres | Lille | France |
| Hôpital Claude Huriez, CHRU | Lille | France |
| Nancy University Hospital | Nancy | 54000 | France |
| Aphp Necker | Paris | 75000 | France |
| APHP Robert Debré | Paris | 75000 | France |
| Aphp St Antoine | Paris | 75000 | France |
| Rouen University Hospital | Rouen | 76000 | France |
| D007410 | Intestinal Diseases |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |