Confocal Laser Endomicroscopy, IBS and Stress

June 30, 2022 updated by: Mark Ellrichmann, University Hospital Schleswig-Holstein

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?

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany, 24105
        • Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stress
Injection of corticotropin releasing factor
Drug: Stress
Corticotropin-Releasing Hormone
Other Names:
  • CRH
Placebo Comparator: Control
Injection of 0.9% saline 10 ml
Drug: Control
Saline 0.9%
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.
Time Frame: immediate
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 12, 2014

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBS stress

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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