Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease from Organoids

Not Applicable

Recruiting

• Conditions: Radiation Enteritis; Inflammatory Bowel Diseases
• Interventions: Other: biopsy

• Registration Number: NCT05425901
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Study Start: 2022-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-09-18
• Study Completion: 2025-09-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBD	biopsy	active or quiescent
control	biopsy	polyp screening

Primary Outcome Measures

Name	Time	Method
Validation of organoid-production method - tight junctions	Day 1	Number of tight junctions between cells 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 - cell growth	Day 1	Cell-growth kinetics
Validation of organoid-production method - cell composition	Day 1	Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing
Validation of organoid-production method - cell apoptosis	Day 1	Cell-apoptosis level assessed by immunofluorescence

Secondary Outcome Measures

Name	Time	Method
Screening-tool setup - quantity	Day 1	Quantity of organoids after irradiation
Screening-tool setup - size	Day 1	Size of organoids after irradiation
In-vitro treatment evaluation - size	Day 1	Size of organoids after irradiation and in presence of treatment
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
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
Screening-tool setup - cell growth	Day 1	Cell-growth kinetics after irradiation
Screening-tool setup - tight junctions	Day 1	Number of tight junctions between cells after irradiation assessed by immunofluorescence
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 compared to native-biopsy cell composition assessed by single-cell RNA sequencing
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 - inflammatory cytokines	Day 1	Level of inflammatory-cytokines produced after irradiation and in presence of treatment assessed by single-cell RNA sequencing
In-vitro treatment evaluation - tight junction	Day 1	Number of tight junctions between cells after irradiation and in presence of treatment assessed by immunofluorescence

Trial Locations

Locations (1)

Groupe Hospitalier Ambroise Paré Hartmann; 🇫🇷 Neuilly-sur-Seine, Hauts-de-Seine, France