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

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ClinicalTrials.gov Identifier: NCT02826330
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date June 29, 2016
First Posted Date July 11, 2016
Last Update Posted Date October 11, 2019
Actual Study Start Date October 3, 2013
Actual Primary Completion Date April 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2016)
Percentage of Lachnospiraceae bacteria in stools within 3 groups [ Time Frame: 1 YEAR ]
After extraction DNA, microbiota will be studied via study of ribosomal DNA 16S using quantitative PCR and pyroséquençage
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 4, 2016)
  • Number of bacteria Firmicutes phylum (including Faecalibacterium prausnitzii and Clostridium Leptum) in stools within 3 groups [ Time Frame: 1 year ]
    After extraction DNA, microbiota will be studied via study of ribosomal DNA 16S using quantitative PCR and pyroséquençage
  • Define different genetic and serologic backgrounds within 3 groups [ Time Frame: 1 year ]
    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.
  • Quantify of bacteria with invasive properties (including AIEC) within 3 groups [ Time Frame: 1 year ]
    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.
  • Study of environmental risk factors within 3 groups [ Time Frame: 1 year ]
    Specific questionnaire on environmental risk factors including vaccination, antibiotic use, ionfections, Home facilities and Diet befor the CD diagnosis
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease
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.
Brief 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.
Detailed 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Family-Based
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
Blood, saliva, stools
Sampling Method Non-Probability Sample
Study Population 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).
Condition
  • Crohn's Disease
  • Genetic Predisposition
Intervention Other: biomarkers
fecal microbiota analysis antibodies in serum and saliva DNA polymorphisms
Other Name: Dysbiosis
Study Groups/Cohorts
  • case Crohn disease
    60 cases with Crohn's Disease
    Intervention: Other: biomarkers
  • first relative healthy
    2 healthy relatives per CD case (total 120)
    Intervention: Other: biomarkers
  • controls
    60 controls matched on gender and age with CD cases
    Intervention: Other: biomarkers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 4, 2016)
240
Original Estimated Enrollment Same as current
Actual Study Completion Date April 3, 2019
Actual Primary Completion Date April 3, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02826330
Other Study ID Numbers 2011_21
2012-A00802-41 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Corinne Gower-Rousseau, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date October 2019