Confocal Laser Endomicroscopy, IBS and Stress

University Hospital Schleswig-Holstein (UKSH)

Status

Withdrawn

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Control

Drug: Stress

Study type

Interventional

Funder types

Other

Identifiers

NCT02316132

IBS stress

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age >18 years
No abdominal symptoms such as bloating and abdominal pain
Barrett's esophagus
Independent indication for confocal laser endomicroscopy for evaluation of Barrett's dysplasia
Written informed consent for participation in this study

Exclusion criteria

Any known other gastrointestinal disease including infection such as helicobacter pylori, Morbus Whipple or others, celiac disease, or chronic inflammatory bowel disease
Active or recent GI Bleeding
Stricture in the upper gastrointestinal tract
Impaired renal function (Creatinine >1.2 mg/dL)
Pregnancy or breast feeding
Inability to obtain informed consent
Known allergy to Methylene blue or Fluorescein
Participation in other clinical trials within the last 4 weeks