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Confocal Laser Endomicroscopy, IBS and Stress

NCT02316132 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-07-06

No results posted yet for this study

Summary

After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is needed for CLE but is not part of the investigation.

Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal mucosa.

Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according to randomisation) will be injected intravenously. Endoscopist and assistant staff will be blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5 min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of fluorescein into the gut lumen and widening of intervillous space.

Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast cell tryptase to identify mast cell activation and numbers.

The procedure will take around 15 minutes in addition to the routine investigation performed prior to the study. A study outline is presented in figure 1.

Samples taken are the same amount as done in the previous food associated study.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Stress

Corticotropin-Releasing Hormone

DRUG

Control

Saline 0.9%

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Annette Fritscher-Ravens, MD, PhD · University Hospital Schleswig-Holstein

  • Mark Ellrichmann, MD · University Hospital Schleswig-Holstein

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02316132 on ClinicalTrials.gov