Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease
MAGIC
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.
2 other identifiers
observational
240
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2013
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2013
CompletedFirst Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2019
CompletedOctober 11, 2019
October 1, 2019
5.5 years
June 29, 2016
October 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Number of bacteria Firmicutes phylum (including Faecalibacterium prausnitzii and Clostridium Leptum) in stools within 3 groups
1 year
Define different genetic and serologic backgrounds within 3 groups
1 year
Quantify of bacteria with invasive properties (including AIEC) within 3 groups
1 year
Study of environmental risk factors within 3 groups
1 year
Study Arms (3)
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
Interventions
fecal microbiota analysis antibodies in serum and saliva DNA polymorphisms
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Amiens University & Hospital
Amiens, 80000, France
cLERMONT fERRAND University Hospital
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
Biospecimen
Blood, saliva, stools
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corinne Gower-Rousseau, MD, PhD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2016
First Posted
July 11, 2016
Study Start
October 3, 2013
Primary Completion
April 3, 2019
Study Completion
April 3, 2019
Last Updated
October 11, 2019
Record last verified: 2019-10