Clinical trial NCT05425901: Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease from Organoids
Official title: Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease from Organoids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Enteritis
Inflammatory Bowel Diseases
Keywords: colonoscopy
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: National Research Agency, France
First posted: 2022-06-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Validation of organoid-production method - quantity
timeFrame: Day 1
measure: Validation of organoid-production method - size
timeFrame: Day 1
measure: Validation of organoid-production method - cell growth
timeFrame: Day 1
measure: Validation of organoid-production method - cell composition
timeFrame: Day 1
measure: Validation of organoid-production method - cell composition
timeFrame: Day 1
measure: Validation of organoid-production method - cell apoptosis
timeFrame: Day 1
measure: Validation of organoid-production method - tight junctions
timeFrame: Day 1
Secondary outcomes:
measure: Screening-tool setup - quantity
timeFrame: Day 1
measure: Screening-tool setup - size
timeFrame: Day 1
measure: Screening-tool setup - cell growth
timeFrame: Day 1
measure: Screening-tool setup - cell composition
timeFrame: Day 1
measure: Screening-tool setup - cell apoptosis
timeFrame: Day 1
measure: Screening-tool setup - tight junctions
timeFrame: Day 1
measure: Screening-tool setup - inflammatory cytokines
timeFrame: Day 1
measure: In-vitro treatment evaluation - quantity
timeFrame: Day 1
measure: In-vitro treatment evaluation - size
timeFrame: Day 1
measure: In-vitro treatment evaluation - cell growth
timeFrame: Day 1
measure: In-vitro treatment evaluation - cell composition
timeFrame: Day 1
measure: In-vitro treatment evaluation - cell composition
timeFrame: Day 1
measure: In-vitro treatment evaluation - cell apoptosis
timeFrame: Day 1
measure: In-vitro treatment evaluation - tight junction
timeFrame: Day 1
measure: In-vitro treatment evaluation - inflammatory cytokines
timeFrame: Day 1
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: Groupe Hospitalier Ambroise Paré Hartmann
state: Hauts-de-Seine
Study officials:
References: