Crohn's DiseaseMAGICNCT02826330
Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease
An observational study of Crohn's Disease and Genetic Predisposition, run by University Hospital, Lille at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 8 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Genetic Predisposition
- What is being tested?
- biomarkers
- How many people
- 240 participants
- Where
- 10 sitesFrance
- Study dates
- 3 Oct 2013to 3 Apr 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Amiens University & Hospital
Amiens, 80000
cLERMONT fERRAND University Hospital
Clermont-Ferrand, 63000
APHP Kremlin Bicêtre
Le Kremlin-Bicêtre
CHRU,Hôpital Jeanne de Flandres
Lille
Hôpital Claude Huriez, CHRU
Lille
Nancy University Hospital
Nancy, 54000
Aphp Necker
Paris, 75000
APHP Robert Debré
Paris, 75000
Aphp St Antoine
Paris, 75000
Rouen University Hospital
Rouen, 76000
About this study
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.
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.
Read the 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 :
- 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.
- Conditions
- Crohn's Disease, Genetic Predisposition
- Being tested
- biomarkers
- Keywords
- Crohn's Disease, Healthy relatives, Dysbiosis, Biomarkers
- Medical subject headings
- Crohn Disease, Genetic Predisposition to Disease, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarkersOther
Also called Dysbiosis
fecal microbiota analysis antibodies in serum and saliva DNA polymorphisms
| Study group | Role | What they receive |
|---|---|---|
| case Crohn disease | 60 cases with Crohn's Disease Receives: Other: biomarkers | |
| first relative healthy | 2 healthy relatives per CD case (total 120) Receives: Other: biomarkers | |
| controls | 60 controls matched on gender and age with CD cases Receives: Other: biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 YEAR
Secondary outcomes (4)
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
Measured: 1 year
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.
Measured: 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.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start3 Oct 2013
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne Gower-Rousseau, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826330
- Sponsor's protocol ID
- 2011_21
- Other IDs
- 2012-A00802-41
- Acronym
- MAGIC
- Status last verified
- Oct 2019
- First submitted
- 29 Jun 2016
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02826330
- Acronym / sponsor ID
- MAGIC / 2011_21
- Conditions
- Crohn's Disease, Genetic Predisposition
- Keywords
- Crohn's Disease, Healthy relatives, Dysbiosis, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Oct 2013 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| case Crohn disease | – | Other: biomarkers60 cases with Crohn's Disease |
| first relative healthy | – | Other: biomarkers2 healthy relatives per CD case (total 120) |
| controls | – | Other: biomarkers60 controls matched on gender and age with CD cases |
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Intestinal resection.
- Pregnant or breastfeeding woman.
- subject under guardianship
- subject does not speak French
- person unable to speak
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biomarkersAlso: Dysbiosisfecal microbiota analysis antibodies in serum and saliva DNA polymorphisms | Other | case Crohn disease, controls, first relative healthy |
Primary outcome
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
4 secondary outcomes
Number of bacteria Firmicutes phylum (including Faecalibacterium prausnitzii and Clostridium Leptum) in stools within 3 groups
Time frame: 1 year
Define different genetic and serologic backgrounds within 3 groups
Time frame: 1 year
Quantify of bacteria with invasive properties (including AIEC) within 3 groups
Time frame: 1 year
Study of environmental risk factors within 3 groups
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Gower-Rousseau, MD, PhD principal investigator
University Hospital, Lille
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Genetic Predisposition, run by University Hospital, Lille at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Lachnospiraceae bacteria in stools within 3 groups (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.