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Completed

NCT Number: NCT02826330

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

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.

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Key information

Age range

8 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amiens University & Hospital, Amiens, France

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About this study

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 :

  • the search for an association between bacterial dysbiosis and different genetic backgrounds in patients with CD, their first degree healthy relatives and controls.
  • 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.
  • a study of environmental risk factors using a questionnaire to be submitted to CD patients, their healthy relatives and control subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biomarkers

Other

fecal microbiota analysis antibodies in serum and saliva DNA polymorphisms

Other names: Dysbiosis

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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.

Acronym: MAGIC

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2016
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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