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

July 3, 2024 updated by: University of Erlangen-Nürnberg Medical School

Establishment of Small Intestinal Human Organoids to Check the Influence of Nutrient Antigens or Therapeutic Agents

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

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

375

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91052
        • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

-Patients with patients with Food intolerances, Food allergy, intestinal disorders, glutensensitivity, healthy controls who underwent a gastroduodenoscopy or coloscopy for therapeutical intervention or screening

Description

Inclusion Criteria:

  • patients with gastrointestinal disorders and therapeutical indication of gastroduodenoscopy or coloscopy
  • healthy controls for preventive medical check-up

Exclusion Criteria:

  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of proliferation, apoptosis, histology, and cytokine Expression before and after Antigen provocation of organoids with gluten peptides, nutritional Antigens, Glucagon like peptide antagonist, or Tumor nekrose factor antagonists
Time Frame: baseline vs 24h vs 48h vs 72h
Determination of effects on organoids after antigen Stimulation with ELISA, histochemistry, RNA or proteome analysis
baseline vs 24h vs 48h vs 72h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • intestinal organoids

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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