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Résztvevőt keres itt: FranciaországFázis nélkül

Study of Tissue Repair in Inflammatory Bowel Disease Exploiting Organoid Technology

A legfontosabb adatok

Ki végzi
Assistance Publique Hopitaux De Marseille
Hol
Marseille (Franciaország)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
60 fő, tervezett
Kezdés
2025. júl. 24.
Várható befejezés
2027. márc. 24.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport színlelt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Colonoscopy - IBD inflamed tissue
  • Surgical resection - IBD inflamed mucous membrane
  • Colonoscopy - biopsies in healthy tissue
  • Surgical resection - healthy mucous membrane
A regiszteradat frissítve
2026. szeptember 21.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akiknek vastagbelet érintő Crohn-betegsége vagy fekélyes vastagbélgyulladása van, valamint IBD nélküli felnőtteket összehasonlító csoportnak. Mindannyiuknál vastagbéltükrözés vagy bélműtét történik.

Életkor
18 éves vagy idősebb
Nem
Nemtől függetlenül részt vehet bárki
A betegség stádiuma
IBD-csoport: vastagbelet érintő Crohn-betegség vagy fekélyes vastagbélgyulladás, a betegség bármely szintjén, súlyosságával és időtartamával.

A részvétel fő kizáró okai

  • Az érzéstelenítés vagy a vastagbéltükrözés ellenjavallt
  • IBD-csoport: a Crohn-betegség vagy a fekélyes vastagbélgyulladás nem érinti a vastagbelet
  • Kontrollcsoport: a vastagbéltükrözés vagy a bélműtét során IBD derül ki
  • Kontrollcsoport: immunmediált gyulladásos betegség (IMID)
  • Cselekvőképtelen felnőttek, szabadságuktól megfosztott személyek, vagy beleegyezés hiánya

A regiszter feltételei, szó szerint

Mind a 28 feltétel megnézéseKevesebb

Egyéb feltételek

  • For IBD group the inclusion criteria will be:
  • Patients of either sex aged 18 years or older
  • Patient that have read the information form and signed consent
  • Patient covered with health insurance
  • Patients 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
  • Patients with colonic involvement of Crohn's disease or ulcerative colitis
  • Patients undergoing a screening colonoscopy in the context of IBD disease follow-up OR undergoing intestinal resection for IBD disease aggravation; For control group the inclusion criteria will be:
  • Patients of either sex aged 18 years or older
  • Patient that have read the information form and signed consent
  • Patient covered with health insurance
  • Patients 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; The non-inclusion criteria for IBD group will be:
  • Contraindication to the anaesthetic or colonoscopy procedure
  • Patients without colonic involvement of Crohn's disease or ulcerative colitis
  • Patients of Adults without legal capacity
  • Patients in Health and Social Establishments
  • Persons in emergency situations
  • Persons deprived of their liberty
  • Non-affiliated to a social security scheme
  • Absence or refusal of the informed consent; The non-inclusion criteria for control group will be:
  • IBD disease revealed during colonoscopy or gastrointestinal resection
  • Patient suffering from Immune-Mediated Inflammatory Diseases (IMIDs)
  • Contraindication to the anaesthetic or colonoscopy procedure
  • Patients of Adults without legal capacity
  • Patients in Health and Social Establishments
  • Persons in emergency situations
  • Persons deprived of their liberty
  • Non-affiliated to a social security scheme
  • Absence or refusal of the informed consent

Helyszínek itt: Franciaország

  • Nord HospitalMarseille, FranciaországContact: Lucas GUILLORésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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:

* Their capacity to proliferate. * Their ability to survive treatment with pro-inflammatory cytokines * The activation of intracellular pathways associated with cell death. * Their overall metabolic activity. * The balance between stem and differentiated epithelial cell types. * The transcriptional activation of protective pathways such as those associated with proliferation, migration, differentiation and cell survival. * To evaluate hallmarks of tissue repair in biopsies 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, and to correlate them to the levels of inflammatory cytokines, luminal metabolites and overall disease severity. Namely the investigators will evaluate the following parameters: * The abundance of proliferating cells. * The activation of intracellular pathways associated with cell death and survival. * Their overall metabolic activity. * The balance between stem and differentiated epithelial cell types. * The transcriptional activation of protective pathways such as those associated with proliferation, migration, differentiation and cell survival.

A vizsgálat 2 csoportja

  • Control groupSzínlelt kezelés, összehasonlításként

    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

    Kezelés: Colonoscopy - biopsies in healthy tissue és Surgical resection - healthy mucous membrane

  • IBD groupA vizsgált kezelés

    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

    Kezelés: Colonoscopy - IBD inflamed tissue, Surgical resection - IBD inflamed mucous membrane és Surgical resection - healthy mucous membrane

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
A regiszteradat frissítve
2026. szeptember 21.