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COmparison of MicroBiota AccordIng to Age in Crohn's Disease (COMeBACk) (COMeBACk)

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ClinicalTrials.gov Identifier: NCT02839317
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

The cause of CD could be different according to age at onset of CD symptoms. Indeed we know that some very young patients at CD diagnosis have particular genetic variants as abnormalities of the IL10R that are regarded as quite monogenic disease. In the other way, the microbiota also undergoes substantial changes at the extremes of life, in infants and older people and the ramifications of which are very few being explored. The comparison of microbiota by principal component analysis and genetic profile of patients with CD beginning at the extremes of life could help us to better known physiopathology of CD according to age and provide arguments that CD beginning at the extremes of life could be different diseases.

The aim of the study is to ascertain through population-based study the hypothesis that gut microbiota is different between paediatric-onset and elderly-onset CD patients in relation with genetic and environmental mechanisms. The results will provide a better knowledge of the etiopathogenic ways in CD and propose a personalized therapeutic care based on age at CD onset (i.e. according to the gut bacteria involved).


Condition or disease Intervention/treatment
Crohn's Disease Biological: Biological

Detailed Description:

The primary aim is to describe by principal component analysis and compare the gut microbiota between subgroups of paediatric-onset (n=75), elderly-onset CD patients (n=75) and control subjects (75 paediatric control and 75 elderly control subjects matched on age) without an a priori approach of high throughput sequencing of bacterial DNA. As it has been shown that the type of IBD-associated dysbiosis depends on ileal involvement, Paediatric-onset and elderly-onset CD patients will be stratified according this parameter.

The secondary aims are:

  • (I) Find specific bacteria involved in paediatric- and elderly-onset patients using PLS Discriminant Analysis (PLS-DA) that is a classical PLS regression (with a regression mode) but where the response variable is categorical.
  • (II) Search for an association between bacterial dysbiosis and different genetic backgrounds in patients according to age at CD onset (paediatric-onset vs elderly-onset) and in control subjects;
  • (III) Quantify of 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 according to age at CD onset and in control subjects; this study will include the comparison of the gut microbiome between subgroups of paediatric-onset, elderly-onset CD patients and control subjects.
  • (IV) Study of environmental risk factors using a questionnaire to be submitted to CD patients and control subjects.

The results would provide a better knowledge of the etiopathogenic ways in CD and would downstream open the way towards clinical trials focused on specific microbiota disorders according to age at CD onset. This project will help to decipher the potential involvement of specific bacteria in the physiopathology of CD. This could lead to the development of new therapeutic strategies either using optimized current treatments targeting bacteria. Data from clinical trials which for the great majority rarely include paediatric patients and set an upper limit for study eligibility at 65 years of age are thus focusing on adult-onset disease. Thus the potential specificities of paediatric- and elderly-onset diseases are not taken into account. A better knowledge of characteristics of CD at the extreme of life will be important to set up innovative clinical trials including specific therapeutics adapted to patients where disease occurred at the extreme age of life, especially as these patients did not benefited of specific trials. The ultimate goal is a better quality of care delivered to paediatric- and elderly-onset CD patients.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Fecal Microbiota Between Patients With Early and Late Crohn's Disease and Relationship With Different Genetic and Serological Profiles
Actual Study Start Date : May 9, 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
Biological in pediatric CD
75 pediatric-onset CD Biological
Biological: Biological
comparison of microbiota, genetic profile between pediatric- and elderly-onset CD
Other Name: Dysbiosis

Biological in pediatric controls
75 pediatric controls matched on gender, age and area of residence Biological
Biological: Biological
comparison of microbiota, genetic profile between pediatric- and elderly-onset CD
Other Name: Dysbiosis

Biological in elderly CD
75 elderly-onset CD Biological
Biological: Biological
comparison of microbiota, genetic profile between pediatric- and elderly-onset CD
Other Name: Dysbiosis

Biological in elderly controls
75 elderly controls matched on gender, age and area of residence Biological
Biological: Biological
comparison of microbiota, genetic profile between pediatric- and elderly-onset CD
Other Name: Dysbiosis




Primary Outcome Measures :
  1. Analysis of microbiota [ Time Frame: 1 YEAR ]
    To describe by principal component analysis and compare the gut microbiota between subgroups of paediatric-onset (n=75), elderly-onset CD patients (n=75) and controls (150).


Secondary Outcome Measures :
  1. Specific bacteria [ Time Frame: 1 YEAR ]
    Find specific bacteria involved in paediatric- and elderly-onset patients using PLS Discriminant Analysis (PLS-DA)

  2. Association between bacterial dysbiosis and different genetic backgrounds [ Time Frame: 1 YEAR ]
    Search for an association between bacterial dysbiosis and different genetic backgrounds in patients according to age at CD onset (paediatric-onset vs elderly-onset) and in controls

  3. Presence of bacteria with invasive properties (E. coli, including adherent-invasive E.coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular) [ Time Frame: 1 YEAR ]
    Quantify of bacteria with invasive properties (E. coli, including adherent-invasive E.coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular)

  4. Environmental risk factors [ Time Frame: 1 YEAR ]
    Study of environmental risk factors using a questionnaire to be submitted to CD patients and controls .


Biospecimen Retention:   Samples With DNA
Stool samples Blood samples (DNA extraction) and sera Salivary samples


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Paediatric- onset (n=75), elderly-onset CD patients (n=75) and control subjects matched on age, gender and geographical origin (urban, periurban and rural area according to INSEE data) in each group (n=150) will be recruited through a large population-based registry of IBD patients (EPIMAD Registry). In 2 case-control studies, controls (n=150) will be matched to cases by age (± 2 years), gender and geographical origin (urban, periurban and rural area according to INSEE data). Control subjects will be recruited through paediatric and geriatric consultations in Lille University Hospital.

The duration of recruitment will be 2 years.

Criteria

Inclusion Criteria:

  • CD patients Patients aged less than 17 years (paediatric-CD group) or more than 40 years (elderly-CD group) at definite or probable CD diagnosis, defined according to Epimad's criteria2,4.

CD diagnosis within 5 years prior inclusion. Patients with CD in remission with or without corticosteroids, 5-ASA or nutrition.

Agreeing to participate in the project and have signed consent, Being insured

  • Control subjects Patients aged less than 17 years (paediatric-control group) or more than 40 years (elderly-control group) Agreeing to participate in the project and have signed consent, Being insured

Exclusion Criteria:

  • Pregnant or lactating Subject who underwent bowel resection Subject taking antibiotics, prebiotics, probiotics or bowel preparation in 6 weeks sampling seat will be temporarily suspended. The sampling will be done remotely and delayed (> 6 weeks) of treatment discontinuation or antibiotic bowel preparation.

A person taking or have taken a topical treatment within 6 weeks before inclusion Persons who have undergone surgical resection Nobody emergency Topic guardianship, curator ship or judicial protection, persons deprived of liberty Subject does not speak French Subject unable to answer questions or express


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839317


Contacts
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Contact: Corinne Gower-Rousseau, MD, PhD +33320445518 corinne.gower@chru-lille.fr
Contact: Sara FRADE sara.frade@chru-lille.fr

Locations
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France
Amiens University & Hospital Not yet recruiting
Amiens, France, 80000
Contact: Mathurin Fumery, MD       mathurinfumery@gmail.com   
Sub-Investigator: Mathurin FUMERY, MD         
Lille Hôpital Huriez Recruiting
Lille, France, 59037
Contact: Catherine Cunisse       catherine.cunisse@chru-lille.fr   
Sub-Investigator: Benjamin Pariente, MD,PhD         
Sub-Investigator: Maria Nachury, MD         
Sub-Investigator: Pierre Desreumaux, MD,PhD         
Lille Jean de Flandre Hospital Recruiting
Lille, France, 59037
Contact: Dominique Turck, MD, PhD       dominique.turck@chru-lille.fr   
Lille University Hospital & EPIMAD Registry Recruiting
Lille, France, 59037
Contact: Corinne GOWER-ROUSSEAU, MD,PhD         
Sub-Investigator: NATHALIE GUILLON, MD         
Rouen University & Hospital Not yet recruiting
Rouen, France, 76000
Contact: Stéphanie Auzou       Stephanie.Auzou@chu-rouen.fr   
Sub-Investigator: Guillaume SAVOYE, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
National Research Agency, France
Investigators
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Principal Investigator: Corinne Gower-Rousseau, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02839317     History of Changes
Other Study ID Numbers: 2013_71
2014-A01225-42 ( Other Identifier: ID-RCB number, ANSM )
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Lille:
Dysbiosis
Crohn's disease
Age

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases