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

Intestine Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03256266
• Other study ID #: intestinal organoids
• Status: Recruiting
• Start date: April 1, 2017
• Est. completion date: July 2023

Study information

• Verified date: January 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Yurdagül Zopf, Prof
• Phone: 49 9131 8545218
• Email: yurdaguel.zopf[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• healthy controls for preventive medical check-up

Exclusion Criteria:

• pregnant women

Related Conditions & MeSH terms

• Intestinal Diseases
• Intestine Disease

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determination of effects on organoids after antigen Stimulation with ELISA, histochemistry, RNA or proteome analysis	baseline vs 24h vs 48h vs 72h