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OpenTrials
Completed

NCT Number: NCT05425901

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

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).

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Key information

Conditions

Radiation Enteritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Ambroise Paré Hartmann

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Other

endoscopy biopsies (6)

Primary outcomes

  1. Validation of organoid-production method - quantity

    Time frame: Day 1

    Quantity of organoids created

  2. Validation of organoid-production method - size

    Time frame: Day 1

    Size of organoids created

  3. Validation of organoid-production method - cell growth

    Time frame: Day 1

    Cell-growth kinetics

  4. Validation of organoid-production method - cell composition

    Time frame: Day 1

    Cell composition assessed by immunofluorescence

  5. Validation of organoid-production method - cell composition

    Time frame: Day 1

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

  6. Validation of organoid-production method - cell apoptosis

    Time frame: Day 1

    Cell-apoptosis level assessed by immunofluorescence

  7. Validation of organoid-production method - tight junctions

    Time frame: Day 1

    Number of tight junctions between cells assessed by immunofluorescence

Secondary outcomes

  1. Screening-tool setup - quantity

    Time frame: Day 1

    Quantity of organoids after irradiation

  2. Screening-tool setup - size

    Time frame: Day 1

    Size of organoids after irradiation

  3. Screening-tool setup - cell growth

    Time frame: Day 1

    Cell-growth kinetics after irradiation

  4. Screening-tool setup - cell composition

    Time frame: Day 1

    Cell composition after irradiation assessed by immunofluorescence

  5. Screening-tool setup - cell apoptosis

    Time frame: Day 1

    Cell-apoptosis level after irradiation assessed by immunofluorescence

  6. Screening-tool setup - tight junctions

    Time frame: Day 1

    Number of tight junctions between cells after irradiation assessed by immunofluorescence

  7. Screening-tool setup - inflammatory cytokines

    Time frame: Day 1

    Level of inflammatory-cytokines produced after irradiation assessed by single-cell RNA sequencing

  8. In-vitro treatment evaluation - quantity

    Time frame: Day 1

    Quantity of organoids after irradiation and in presence of treatment

  9. In-vitro treatment evaluation - size

    Time frame: Day 1

    Size of organoids after irradiation and in presence of treatment

  10. In-vitro treatment evaluation - cell growth

    Time frame: Day 1

    Cell-growth kinetics after irradiation and in presence of treatment

  11. In-vitro treatment evaluation - cell composition

    Time frame: Day 1

    Cell composition after irradiation and in presence of treatment assessed by immunofluorescence

  12. In-vitro treatment evaluation - cell composition

    Time frame: Day 1

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

  13. In-vitro treatment evaluation - cell apoptosis

    Time frame: Day 1

    Cell-apoptosis level after irradiation and in presence of treatment assessed by immunofluorescence

  14. In-vitro treatment evaluation - tight junction

    Time frame: Day 1

    Number of tight junctions between cells after irradiation and in presence of treatment assessed by immunofluorescence

  15. In-vitro treatment evaluation - inflammatory cytokines

    Time frame: Day 1

    Level of inflammatory-cytokines produced after irradiation and in presence of treatment assessed by single-cell RNA sequencing

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • National Research Agency, France

Registry information

Acronym: INTRUST

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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