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

Last updated: March 25, 2025
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infectious Colitis

Gastroenteritis

Gastrointestinal Diseases And Disorders

Treatment

biopsy

Clinical Study ID

NCT05425901
C20-53
2021-A02973-38
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Group 1: active IBD

  • 18 years old or older

  • Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to EuropeanCrohn's and Colitis Organisation (ECCO) 2019 consensus criteria

  • Active IBD (Harvey-Bradshaw score of 4 or above for Crohn's disease or partial Mayoscore 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 2019consensus criteria

  • Inactive IBD (Harvey-Bradshaw score below 4 for Crohn's disease or partial Mayoscore 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

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 ofintestinal 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

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: biopsy
Phase:
Study Start date:
September 19, 2022
Estimated Completion Date:
September 18, 2025

Connect with a study center

  • Hopital Beaujon

    Clichy, Hauts De Seine 92120
    France

    Site Not Available

  • Groupe Hospitalier Ambroise Paré Hartmann

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

    Active - Recruiting

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