CompletedNot Applicable

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

France214 participantsStarted 2016-05-09

Plain-language 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).

Who can participate

Age range

8 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Analysis of microbiota

Timeframe: 1 YEAR

Trial details

NCT IDNCT02839317

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-22

View on ClinicalTrials.gov More Crohn's Disease trials