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Confocal Laser Endomicroscopy, IBS and Stress

Confocal Endomicroscopy for the Detection of Food Intolerances in Patients With IBS: Add on Control Group: Does Stress Cause Similar Mucosal Changes to Food Antigens?

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02316132
Enrollment
0
Registered
2014-12-12
Start date
2014-12-31
Completion date
2016-07-31
Last updated
2022-07-06

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

Conditions

Irritable Bowel Syndrome

Brief 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.

Interventions

DRUGStress

Corticotropin-Releasing Hormone

DRUGControl

Saline 0.9%

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.immediate

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026