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Active, not recruitingNCT03256266Updated Jul 5, 2024

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

An observational study in Intestine Disease, sponsored by University of Erlangen-Nürnberg Medical School. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by University of Erlangen-Nürnberg Medical School · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
375
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Intestine Disease

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnant women
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
375 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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

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

    Time frame: baseline vs 24h vs 48h vs 72h

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Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03256266
Lead sponsor
University of Erlangen-Nürnberg Medical School
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Apr 1, 2017
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Jul 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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