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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03256266

Enrollment

375

Registered

2017-08-22

Start date

2017-04-01

Completion date

2025-07-31

Last updated

2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestine Disease

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Germany

Outcome results