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Recruiting NCT05294107

Intestinal Organoids

No phase Interventional Digestive System Diseases Inflammatory Bowel Disease, Ulcerative Colitis Type Crohn Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: additional biopsies.
Who it may be relevant to
Registry conditions: Digestive System Diseases, Inflammatory Bowel Disease, Ulcerative Colitis Type, Crohn Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Over the last decade, the use of mini-organ or organoids has been increasingly developed in fundamental research. Indeed, digestive organoids represent an essential advance compared to classical culture systems (epithelial cell lines, immortalized cells) since they preserve in culture the functional complexity present in vivo (architecture, different cell types). They also have the advantage of being able to be propagated indefinitely (unlike explants), minimizing the use of animal models and reducing the amount of tissue required. Finally, their growth and development depends on the origin of the sample (the organoid will develop differently if the cell source comes from a patient suffering from an inflammatory bowel disease, for example), thus generating models of human pathologies to better determine their physiopathology. The use of organoids in biomedical research has proven to be an indispensable tool for the understanding of cellular and molecular mechanisms involved in epithelial renewal and the screening of molecules and ingredients for applications in the health and agri-food sectors.

Detailed description

The project aims to generate a biocollection of 3D intestinal models from digestive biopsies with associated health data and to characterize them before using them for the screening of potential therapeutic molecules.

Interventions

  • Procedure additional biopsies
    After Verification of eligibility criteria, patient information and consent, digestive biopsies performed for the study are in addition to those performed for the patient's follow-up: * 6 biopsies are taken on average in clinical routine * 4 additional biopsies are necessary to obtain a sufficient number of amplifiable stem cells The samples will be sent within one hour to the Biological Resource Center of the University Hospital of Rennes at room temperature in a tube containing isotonic salin

Primary outcome measures

  • Number of isolated intestinal crypts per biopsies [Time frame: Day 0]
Secondary outcome measures (4)
  • Number of differentiated organoids [Time frame: Day 0]
  • Fold change of MUC2 expression [Time frame: Day 0]
  • Fold change of LGR5 expression [Time frame: Day 0]
  • KI67 expression [Time frame: Day 0]

Eligibility criteria

Inclusion criteria

  • Subjects aged 18 to 75 years
  • Subject undergoing endoscopy as part of the standard of care with the need to take digestive biopsy samples
  • Subject having signed a free and informed consent in writing

Exclusion criteria

  • Subjects under legal protection (safeguard of justice, curatorship or guardianship) or deprived of liberty.
  • Anticoagulant treatment and anti-platelet treatment (except for aspirin 75 mg)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de RENNES-Service des Maladies de l'Appareil Digestif — Rennes

Identifiers

NCT: NCT05294107 · 35RC21_8862_BIOÏDES

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗