Confocal Laser Endomicroscopy, IBS and Stress
Primary Purpose
Irritable Bowel Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Stress
Control
Sponsored by
About this trial
This is an interventional diagnostic trial for Irritable Bowel Syndrome
Eligibility Criteria
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
Sites / Locations
- Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Stress
Control
Arm Description
Injection of corticotropin releasing factor
Injection of 0.9% saline 10 ml
Outcomes
Primary Outcome Measures
visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.
Secondary Outcome Measures
Full Information
NCT ID
NCT02316132
First Posted
December 5, 2014
Last Updated
June 30, 2022
Sponsor
University Hospital Schleswig-Holstein
1. Study Identification
Unique Protocol Identification Number
NCT02316132
Brief Title
Confocal Laser Endomicroscopy, IBS and Stress
Official Title
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?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No appropriate participants
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress
Arm Type
Active Comparator
Arm Description
Injection of corticotropin releasing factor
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Injection of 0.9% saline 10 ml
Intervention Type
Drug
Intervention Name(s)
Stress
Other Intervention Name(s)
CRH
Intervention Description
Corticotropin-Releasing Hormone
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
Saline
Intervention Description
Saline 0.9%
Primary Outcome Measure Information:
Title
visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.
Time Frame
immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette Fritscher-Ravens, MD, PhD
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Ellrichmann, MD
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Confocal Laser Endomicroscopy, IBS and Stress
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