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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02826330
Other study ID # 2011_21
Secondary ID 2012-A00802-41
Status Completed
Phase
First received
Last updated
Start date October 3, 2013
Est. completion date April 3, 2019

Study information

Verified date October 2019
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date April 3, 2019
Est. primary completion date April 3, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
biomarkers
fecal microbiota analysis antibodies in serum and saliva DNA polymorphisms

Locations

Country Name City State
France Amiens University & Hospital Amiens
France cLERMONT fERRAND University Hospital Clermont FERRAND
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
France Aphp Necker Paris
France APHP Robert Debré Paris
France Aphp St Antoine Paris
France Rouen University Hospital Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Define different genetic and serologic backgrounds within 3 groups 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
Secondary 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
Secondary 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
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