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Effect of Antigens or Therapeutic Agents on in Vitro Human Intestinal Organoids

Sponsor
University of Erlangen-Nürnberg Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT03256266
Collaborator
(none)
375
Enrollment
1
Location
75
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study evaluates the effect of nutrient antigens or therapeutic agents on human small intestinal organoids.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Small intestinal biopsies will be taken to establish human intestinal organoids in vitro. The organoids will be propagated and various antigens will be checked for their effects on proliferation, production of inflammatory components or signal cascade.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    375 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Establishment of Small Intestinal Human Organoids to Check the Influence of Nutrient Antigens or Therapeutic Agents
    Actual Study Start Date :
    Apr 1, 2017
    Anticipated Primary Completion Date :
    Jul 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    healthy controls

    healthy controls
    patients with allergy

    patients with Food intolerances or Food allergy
    gastrointestinal disorders

    patients with inflammatory bowel disease, irritable bowel disease, gluten sensitivity, short bowel syndrome

    Outcome Measures

    Primary Outcome Measures

    1. Determination of proliferation, apoptosis, histology, and cytokine Expression before and after Antigen provocation of organoids with gluten peptides, nutritional Antigens, GLP-antagonist, or TNF antagonists [baseline vs 24h vs 48h vs 72h]

      Determination of effects on organoids after antigen Stimulation with ELISA, histochemistry, RNA or proteome analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • patients with gastrointestinal disorders and therapeutical indication of gastroduodenoscopy or coloscopy

    • healthy controls for preventive medical check-up

    Exclusion Criteria:
    • pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg Erlangen Germany 91052

    Sponsors and Collaborators

    • University of Erlangen-Nürnberg Medical School

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Erlangen-Nürnberg Medical School
    ClinicalTrials.gov Identifier:
    NCT03256266
    Other Study ID Numbers:
    • intestinal organoids
    First Posted:
    Aug 22, 2017
    Last Update Posted:
    May 13, 2022
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Intestinal Diseases

    Study Results

    No Results Posted as of May 13, 2022