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

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

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Key information

Conditions

Intestine Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Erlangen, 91052, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

pregnant women

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2025
Study completion: 2025
First posted: Aug 22, 2017
Registry last updated: Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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