An interventional study of Colonoscopy - IBD inflamed tissue and Surgical resection - IBD inflamed mucous membrane in Crohn Disease, Inflammatory Bowel Diseases (IBD) and Ulcerative Colitis (Disorder), sponsored by Assistance Publique Hopitaux De Marseille. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Basic science
Among 316 studies in Crohn Disease with a site in France — 80 open to participants now, 104 under way, 29 of them phase 3. Crohn Disease · France.
Among the 316 studies in Crohn Disease with a site in France, this one is the 171st largest by planned enrollment of the 228 interventional ones that give a count, is one of 27 that started in 2025, is one of 62 with no phase, reaches primary completion later than 42 of the 103 other live ones, and was the 283rd registered.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
Browse Crohn Disease studies →80 of the 316 studies in Crohn Disease with a site in France are open now. Recruiting first, the newest first:
Central Hospital, Nancy, France · Sites in France
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Sites in France
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Sites in France
Janssen Research & Development, LLC · Sites in France, United States, Argentina and 27 more countries
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 354 Crohn Disease studies recruiting now, 155 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 96 take children under 18; 56 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
316 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 64 · Phase 3 86 · Phase 4 16
First in 1990; this study’s year is marked. 27 started in 2025.
This study's planned enrollment of 60 is below the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Median enrollment 147 across the 228 interventional studies, 240 across the 87 observational. Of the 194 that completed or were terminated, 78 (40%) have results posted.
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150 of 316 have an industry lead sponsor. The 10 most frequent:
Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
Assistance Publique Hopitaux De Marseille has 7 studies filed under Crohn Disease — fewer than ten, so there is no comparison to draw.
33 of the studies in Crohn Disease with a site in France that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04777656Phase 3Assistance Publique - Hôpitaux de ParisUse of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. | 2026-11 |
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT04997733Phase 3Assistance Publique - Hôpitaux de ParisFecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal | 2027-05-22 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT06227910Phase 3TakedaA Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease | 2027-06-08 |
Among the 316 studies in Crohn Disease with a site in France, from their registry updates:
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Inflammatory Bowel Diseases (IBD) are chronic inflammations of the gastrointestinal tract. Regardless of the etiology, a common trait of IBD pathogenesis is the inflammatory damage inflicted on the intestinal mucosa and the loss of intestinal epithelial barrier integrity. Therefore, understanding the mechanisms that govern IEC's capacity to maintain barrier function and to orchestrate mucosal healing is considered a major goal in translational research. The investigators are interested in understanding how the inflammatory environment present in the intestinal mucosa, of IBD patients influences epithelial cells capacity to govern repair. The complexities of the cytokine and metabolic milieu present in IBD patients render the study of the contribution of each cytokine, metabolite, and intracellular pathway extremely complicated. Therefore, most of the processes that govern tissue regeneration are studied with the use of mouse models that recapitulate one or multiple features of IBD and allow for genetical modifications of the gene and pathway of interest. While mouse models are uniquely suited to study the complex crosstalk between the immune system, the microbiota, and the intestinal epithelia, they introduce the important problem of species-specific differences, which can hamper the translational value of mouse studies.
To overcome these shortcomings, the investigators propose to explore the influence of cytokines and metabolites in digestive organoids derived from patients and controls. Importantly, it was demonstrated that gene expression and innate immune responses are altered in primary organoids derived from patients with IBD, including altered ability to proliferate, respond to cytokines, metabolic capacity, and efficiently form organoids suggesting that major differences between patient's and control's epithelial cell biology can be faithfully replicated in this system.
Given these premises, the investigators propose the following objectives:
Primary objective:
The main objective of this study is to establish that patient's epithelial cells from inflamed mucosae have decreased ability to repair the intestinal mucosa, as compared to epithelial cells from non-inflamed regions in the same patient, or to control subject with no inflammatory digestive diseases.
The investigators will explore this question both deriving organoids from clinical samples and exposing them to pro inflammatory cytokines and metabolites in vitro, as well as by analyzing repair responses from the aforementioned clinical samples ex vivo.
Secondary objective
The secondary goals of this study are:
- To compare organoids derived from: epithelia in inflamed mucosa of IBD patients, epithelia in non-inflamed mucosa of IBD patients, and epithelia from the mucosa of non-IBD controls in their capacity to mount a repair response in response to inflammatory cytokines or luminal metabolites.
Namely the investigators will evaluate the following parameters:
For IBD group the inclusion criteria will be:
For control group the inclusion criteria will be:
The non-inclusion criteria for IBD group will be:
The non-inclusion criteria for control group will be:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients of either sex aged 18 years or older and undergoing a screening colonoscopy in the context of a family history of colonic neoplasia, follow-up of colonic polyps or functional intestinal disorders OR undergoing intestinal resection for intestinal neoplasia, occlusive syndrome or colostomy
Procedure: Colonoscopy - biopsies in healthy tissue · Procedure: Surgical resection - healthy mucous membrane
Patients of either sex aged 18 years or older with Crohn's Disease or ulcerative colitis in accordance with accepted clinical, endoscopic, histological and/or radiologic criteria, regardless of the level, severity of the disease or duration of disease progression or patients undergoing a screening colonoscopy in the context of IBD disease follow-up OR undergoing intestinal resection for IBD disease aggravation
Procedure: Colonoscopy - IBD inflamed tissue · Procedure: Surgical resection - IBD inflamed mucous membrane · Procedure: Surgical resection - healthy mucous membrane
Collection of 10 colonic biopsies in IBD inflamed tissue
Collection of a portion of IBD inflamed mucous membrane
Collection of 10 colonic biopsies in healthy tissue
Collection of a portion of healthy mucous membrane
Repair status of IBD patient's epithelial cells from inflamed mucosae
To establish that patient's epithelial cells from inflamed mucosae have decreased ability to repair the intestinal mucosa, as compared to epithelial cells from non-inflamed regions in the same patient, or to control subject with no inflammatory digestive diseases
Time frame: From enrollmet to the end of following at 1 month
Evaluate the molecular mechanism involved in the reduced capacity of epithelial cells of IBD patients to repair intestinal mucosa
Evaluation of: * The capacity epithelial cells of IBD patients to proliferate: ratio of Ki67+cells. * The ability of epithelial cells of IBD patients to survive treatment with pro-inflammatory cytokines: ratio between live and dead organoids. * The activation of intracellular pathways associated with cell death: relative quantification of biochemical activation of 1) apoptotic caspases,2) pyroptosis effectors (GSDMs),3) Necroptosis effectors (MLKL). * The balance between stem and differentiated epithelial cell types: the relative gene expression of the stemness associated genes LGR5, OLFM4, and the hallmark genes of differentiated cell types AQP8, MUC2, LYZ1, CHGA).
Time frame: From enrollment to the end of following at 1 month
Genetically determine the involvement of cell death and protective pathways that reduce repair capacity in patients.
After a genetically modify with CRISPR-CAS9 technology: * The capacity of modified epithelial cells of IBD patients to proliferate: ratio of Ki67+cells. * The ability of modified epithelial cells of IBD patients to survive treatment with pro-inflammatory cytokines: ratio between live and dead organoids. * The activation of intracellular pathways associated with cell death: relative quantification of biochemical activation of 1) apoptotic caspases,2) pyroptosis effectors (GSDMs),3) Necroptosis effectors (MLKL). * The balance between stem and differentiated epithelial cell types: the relative gene expression of the stemness associated genes LGR5, OLFM4, and the hallmark genes of differentiated cell types AQP8, MUC2, LYZ1, CHGA).
Time frame: From enrollment to the end of following at 1 month
3. Explore the activation of molecular mechanisms identified in patient biopsies and correlate them with the inflammatory environment present in the patient's tissues
* Proliferation in FFPE biopsies and RNA from RNAlater fixed biopsies: Ki67 upregulation by immunohistochemistry (IHC), PCNA gene expression, Proliferation transcriptional signature by RNAseq etc…). * Cell death by biochemical analysis of cell death pathways by Western Blot (WB) and IHC in flash frozen biopsies: relative quantification of biochemical activation of 1) apoptotic caspases; 2) pyroptosis effectors (GSDMs); 3) Necroptosis effectors (MLKL). * Differentiation status of epithelial cells from DMSO conserved biopsies: staining of cell type markers by IHC, scRNAseq of dissociated epithelial cells. * The metabolic landscape of epithelial cells in flash frozen biopsies: the metabolome of the cells.
Time frame: From enrollment to the end of following at 1 month
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Mar 2027, 20 months after the start.
Of 287 non-industry interventional studies with no phase under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 67. This study's planned 20 months is below that.
Counting every sponsor, half of 299 studies reached it within 45 months; a quarter within 21 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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