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

NCT05425901 | Completed

• 2 other identifiers: C20-532021-A02973-38
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Radiation Enteritis; Inflammatory Bowel Diseases

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (7)

• Validation of organoid-production method - quantity

  Quantity of organoids created

  Day 1

• Validation of organoid-production method - size

  Size of organoids created

  Day 1

• Validation of organoid-production method - cell growth

  Cell-growth kinetics

  Day 1

• Validation of organoid-production method - cell composition

  Cell composition assessed by immunofluorescence

  Day 1

• Validation of organoid-production method - cell composition

  Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing

  Day 1

• Validation of organoid-production method - cell apoptosis

  Cell-apoptosis level assessed by immunofluorescence

  Day 1

• Validation of organoid-production method - tight junctions

  Number of tight junctions between cells assessed by immunofluorescence

  Day 1

Secondary Outcomes (15)

• Screening-tool setup - quantity

  Day 1

• Screening-tool setup - size

  Day 1

• Screening-tool setup - cell growth

  Day 1

• Screening-tool setup - cell composition

  Day 1

• Screening-tool setup - cell apoptosis

  Day 1

Study Arms (2)

IBD

EXPERIMENTAL

active or quiescent

Other: biopsy

control

ACTIVE COMPARATOR

polyp screening

Other: biopsy

Interventions

biopsy OTHER

endoscopy biopsies (6)

IBD; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Group 1: active IBD
• 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
• \- Group 2: inactive IBD
• 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
• \- Group 3: Control
• years old or older
• Indication to perform a coloscopy to detect polyp

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• National Research Agency, France: collaborator

Study Sites (1)

Groupe Hospitalier Ambroise Paré Hartmann

Neuilly-sur-Seine, Hauts-de-Seine, 92200, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: September 19, 2022
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

FR (1)