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

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ \- 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

Locations
Other Locations
France
Groupe Hospitalier Ambroise Paré Hartmann
Neuilly-sur-seine
Time Frame
Start Date: 2022-09-19
Completion Date: 2024-12-11
Participants
Target number of participants: 16
Treatments
Experimental: IBD
active or quiescent
Active_comparator: control
polyp screening
Sponsors
Collaborators: National Research Agency, France
Leads: Institut National de la Santé Et de la Recherche Médicale, France

This content was sourced from clinicaltrials.gov

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