Evaluating treatments for intestinal issues using organoid cultures
Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease from Organoids
This study is testing new treatments for inflammatory bowel disease by growing tiny organ-like structures from patients' biopsies to see how they respond to different therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Neuilly-sur-Seine, Hauts-de-Seine) |
| Trial ID | NCT05425901 on ClinicalTrials.gov |
What this trial studies
This study involves patients with inflammatory bowel disease (IBD) and healthy individuals undergoing ileocolonoscopy. It focuses on generating and culturing organoids from biopsies taken during the procedure to validate the organoid production method. The second phase aims to screen these organoids by irradiating them and assessing the regenerative effects of various treatments for IBD and radiation enteritis. This innovative approach could lead to better therapeutic strategies for managing these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with either active or inactive IBD or healthy individuals requiring a colonoscopy.
Not a fit: Patients without a diagnosis of IBD or those not requiring a colonoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from inflammatory bowel diseases and radiation enteritis.
How similar studies have performed: While the use of organoids in research is gaining traction, this specific approach to evaluate treatments for IBD and radiation enteritis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Neuilly-sur-Seine, Hauts-de-Seine
- Groupe Hospitalier Ambroise Paré Hartmann — Neuilly-sur-Seine, Hauts-de-Seine, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.