- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02316132
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?
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
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kiel, Germany, 24105
- Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Corticotropin-Releasing Hormone
Other Names:
|
Placebo Comparator: Control
Injection of 0.9% saline 10 ml
|
Saline 0.9%
Other Names:
|
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Irritable Bowel Syndrome
-
ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
-
ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
-
Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
-
Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
-
University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
-
University of ViennaCompleted
-
Thomayer University HospitalCharles University, Czech RepublicActive, not recruitingIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome MixedCzechia
-
Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
-
Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
-
Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
Clinical Trials on Stress
-
Université de MontréalInstitut de Recherche Robert-Sauvé en Santé et en Sécurité du TravailUnknown
-
University of California, Los AngelesUCLA Norman Cousins Center for PsychoneuroimmunologyCompleted
-
Nova Scotia Health AuthorityNot yet recruiting
-
University of California, IrvineCompletedStress, Psychological | Pregnancy Related | Insulin Sensitivity/Resistance | Emotional Stress | Postprandial Hyperglycemia | Glucose Intolerance During PregnancyUnited States
-
Massachusetts General HospitalNational Center for Complementary and Integrative Health (NCCIH)CompletedStress, Psychological | Stress, PhysiologicalUnited States
-
Oslo University HospitalNorwegian Cancer SocietyActive, not recruitingCancer | Stress, PsychologicalNorway
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingBlood Pressure | Psychological StressUnited States
-
Rutgers, The State University of New JerseyCompletedMBSR-STEM | PMR-STEM | MBSR-NON-STEM | PMR -NON-STEMUnited States
-
Walter Reed Army Medical CenterUnknownCoronary Artery Disease | Chest Pain | Coronary Atherosclerosis | Stress TestingUnited States
-
Milton S. Hershey Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Georgetown... and other collaboratorsRecruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type 1 | StressUnited States