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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 8 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02839317
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Lille
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Corinne Gower-Rousseau, MD, PhD
Principal Investigator Affiliation University Hospital, Lille
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Additional Details

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.#46;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.

Arms & Interventions

Arms

: Biological in pediatric CD

75 pediatric-onset CD Biological

: Biological in pediatric controls

75 pediatric controls matched on gender, age and area of residence Biological

: Biological in elderly CD

75 elderly-onset CD Biological

: Biological in elderly controls

75 elderly controls matched on gender, age and area of residence Biological

Interventions

Biological: - Biological

comparison of microbiota, genetic profile between pediatric- and elderly-onset CD

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Amiens University & Hospital, Amiens, France

Status

Not yet recruiting

Address

Amiens University & Hospital

Amiens, , 80000

Site Contact

Mathurin Fumery, MD

mathurinfumery@gmail.com

+33320445518

Lille Hôpital Huriez, Lille, France

Status

Recruiting

Address

Lille Hôpital Huriez

Lille, , 59037

Site Contact

Catherine Cunisse

catherine.cunisse@chru-lille.fr

+33320445518

Lille Jean de Flandre Hospital, Lille, France

Status

Recruiting

Address

Lille Jean de Flandre Hospital

Lille, , 59037

Site Contact

Dominique Turck, MD, PhD

dominique.turck@chru-lille.fr

+33320445518

Lille, France

Status

Recruiting

Address

Lille University Hospital & EPIMAD Registry

Lille, , 59037

Site Contact

Corinne GOWER-ROUSSEAU, MD,PhD

corinne.gower@chru-lille.fr

+33320445518

Rouen University & Hospital, Rouen, France

Status

Not yet recruiting

Address

Rouen University & Hospital

Rouen, , 76000

Site Contact

Stéphanie Auzou

Stephanie.Auzou@chu-rouen.fr

+33320445518

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