Inflammatory Bowel Diseases, Radiation Enteritis
Conditions
Keywords
colonoscopy
Brief summary
This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or colonic mucosa during an ileo-colonoscopy. These cultures will make it possible to validate the organoid production method used in the context of the research (primary objective). In a second phase (secondary objectives), the study will aim to setup a screening tool by irradiating the organoids (step one) and then evaluate in vitro the regenerative activity of treatments dedicated to improve inflammatory bowel diseases and acute radiation enteritis (step two).
Interventions
OTHERbiopsy
endoscopy biopsies (6)
Sponsors
National Research Agency, France
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Group 1: active IBD * 18 years old or older * Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to European Crohn's and Colitis Organisation (ECCO) 2019 consensus criteria * Active IBD (Harvey-Bradshaw score of 4 or above for Crohn's disease or partial Mayo score of 3 or above for ulcerative colitis) * Indication to perform a coloscopy * Written consent for study participation obtained Or \- Group 2: inactive IBD * 18 years old or older * Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to ECCO 2019 consensus criteria * Inactive IBD (Harvey-Bradshaw score below 4 for Crohn's disease or partial Mayo score below 3 for ulcerative colitis) * Indication to perform a coloscopy * Written consent for study participation obtained Or \- Group 3: Control * 18 years old or older * Indication to perform a coloscopy to detect polyp * No known bowel disease * Written consent for study participation obtained
Exclusion criteria
* Inability to understand, read, sign informed consent and/or express consent * Person subject to legal protection (curator, guardianship or safeguard of justice), * Deprivation of liberty by judicial or administrative decision, * Non-affiliation to a social security scheme or non-beneficiary of such a scheme * Pregnant, parturient, breastfeeding women * Contraindication to performing biopsies * Participation in other therapeutic research that may modify the behavior of intestinal cells (for example, drug research for the treatment of IBD) * Anticoagulant treatment or bleeding disorder * Person subject to a judicial safeguard measure * People hospitalized without consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of organoid-production method - cell growth | Day 1 | Cell-growth kinetics |
| Validation of organoid-production method - cell composition | Day 1 | Cell composition assessed by immunofluorescence |
| Validation of organoid-production method - cell apoptosis | Day 1 | Cell-apoptosis level assessed by immunofluorescence |
| Validation of organoid-production method - quantity | Day 1 | Quantity of organoids created |
| Validation of organoid-production method - size | Day 1 | Size of organoids created |
| Validation of organoid-production method - tight junctions | Day 1 | Number of tight junctions between cells assessed by immunofluorescence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screening-tool setup - tight junctions | Day 1 | Number of tight junctions between cells after irradiation assessed by immunofluorescence |
| Screening-tool setup - inflammatory cytokines | Day 1 | Level of inflammatory-cytokines produced after irradiation assessed by single-cell RNA sequencing |
| In-vitro treatment evaluation - quantity | Day 1 | Quantity of organoids after irradiation and in presence of treatment |
| In-vitro treatment evaluation - size | Day 1 | Size of organoids after irradiation and in presence of treatment |
| In-vitro treatment evaluation - cell growth | Day 1 | Cell-growth kinetics after irradiation and in presence of treatment |
| In-vitro treatment evaluation - cell composition | Day 1 | Cell composition after irradiation and in presence of treatment assessed by immunofluorescence |
| In-vitro treatment evaluation - cell apoptosis | Day 1 | Cell-apoptosis level after irradiation and in presence of treatment assessed by immunofluorescence |
| In-vitro treatment evaluation - tight junction | Day 1 | Number of tight junctions between cells after irradiation and in presence of treatment assessed by immunofluorescence |
| In-vitro treatment evaluation - inflammatory cytokines | Day 1 | Level of inflammatory-cytokines produced after irradiation and in presence of treatment assessed by single-cell RNA sequencing |
| Screening-tool setup - quantity | Day 1 | Quantity of organoids after irradiation |
| Screening-tool setup - size | Day 1 | Size of organoids after irradiation |
| Screening-tool setup - cell growth | Day 1 | Cell-growth kinetics after irradiation |
| Screening-tool setup - cell composition | Day 1 | Cell composition after irradiation assessed by immunofluorescence |
| Screening-tool setup - cell apoptosis | Day 1 | Cell-apoptosis level after irradiation assessed by immunofluorescence |
Countries
France
Outcome results
None listed