Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtialis

About this trial

The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such marker(s) in blood.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female ≥ 18 years old

Able to follow the instructions of the study

Having signed an informed consent

A confirmed diagnosis of IBD

Disqualifiers

Commercial Pharmaceutical probiotic administration within the previous month

Treatment with antibiotics (whatever the route of administration) within last 3 months

Non-remission Cancer or in remission for less than 6 months

Any contraindication to colonoscopy and/or biopsy, left to PI discretion

Trial design

Design model

Parallel

Treatments tested in this trial

  • biological samples collection

    Procedure/Surgery

    Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Inflammatory bowel disease cohortOther 1 intervention
Group B: Control cohortOther 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients recruited in each cohort

60 patients in IBD cohort and 60 patients in control cohort

Time frame
27 months
2

number of faeces samples collected in each cohort

60 patients in IBD cohort and 60 patients in control cohort

Time frame
27 months
3

Number of plasma samples collected in each cohort

60 patients in IBD cohort and 60 patients in control cohort

Time frame
27 months
4

Number of biopsy samples collected in each cohort

60 patients in IBD cohort and 60 patients in control cohort with 4 colonic biopsies/ patient

Time frame
27 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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