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

Institut National de la Santé Et de la Recherche Médicale, France

Status: Completed

Conditions: Radiation Enteritis; Inflammatory Bowel Diseases

Treatments: Other: biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05425901

C20-53

2021-A02973-38 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

IBD

Experimental group

Description:

active or quiescent

Treatment:

Other: biopsy

control

Active Comparator group

Description:

polyp screening

Treatment:

Other: biopsy