Endomicroscopy and Food Intolerance

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Schleswig-Holstein
Sponsor:
Collaborators:
Great Ormond Street Hospital for Children NHS Foundation Trust
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Mark Ellrichmann, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01692613
First received: September 20, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

Background:

The immediate endoscopic identification and diagnosis of intraepithelial structures and immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet goals in the diagnosis and management of subjects with food intolerances, who are negative to all available tests. Endomicroscopy may be helpful to further visualize and characterize unmasked small bowel reactions to foods, which has not been described before.

Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the macroscopic view ,which enables the examiner to see immediate reactions after exposure and it further allows capturing of fluid excreted by the gut for further analysis to understand the pathology behind this reaction further.

N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and negative testing with routine methods. Patients with Lactose intolerance n=10 patients to compare results. Patients with Fructose intolerance n=10 patients to compare results. Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain (n=10) to serve as healthy controls for allergy testing.

Methods:

The primary objective is to investigate whether endomicroscopy will allow the detection of an allergic reaction of the gut after exposure of the 5 major allergens in the following way:

After standard gastroscopy with the endomicroscope including evaluation of the surface of the upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation of the duodenal surface including count of initial lymphocytes/mononuclear cells in the lamina propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple), allergen 5 (yeast).

The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.


Condition
Endomicroscopy
Inflammatory Bowel Syndrome
Food Intolerance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Confocal Endomicrosopy for the Detection of Food Intolerance in Patients With Irritable Bowel Syndrome

Further study details as provided by University of Schleswig-Holstein:

Biospecimen Retention:   Samples Without DNA
  • duodenal biopsies
  • duodenal fluid

Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Detailed Description:

The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and negative testing with routine methods
  • N=10 patients with Lactose intolerance
  • N=10 patients with Fructose intolerance
  • N=10 volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain (n=10) to serve as healthy controls for allergy testing
Criteria

Inclusion Criteria:

  • age > 18 years
  • ongoing abdominal symptoms such as bloating and abdominal pain
  • negative routine testing for food intolerance (or known lactose/fructose intolerance)
  • written informed consent

Exclusion Criteria:

  • no consent
  • known reason for the abdominal pain and bloating other than lactose/fructose intolerance
  • M. Whipple
  • known infectious gastrointestinal disease
  • stricture in the upper gastrointestinal tract
  • age >18years
  • impaired renal function (Creatinine >1.2 mg/dL)
  • pregnancy or breast feeding
  • inability to obtain informed consent
  • active GI Bleeding
  • known allergy to Methylene blue or Fluorescein
  • participation in other clinical trials within the last 4 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692613

Contacts
Contact: Annette Fritscher-Ravens, Prof. Dr. 00494315972311 fri.rav@btopenworld.com

Locations
Germany
University Hospital Schleswig Holstein, Campus Kiel, Unit Experimental Endoscopy Recruiting
Kiel, Germany, 24105
Contact: Annette Fritscher-Ravens, Prof. Dr.    00494315972311    fri.rav@btopenworld.com   
Contact: Mark Ellrichmann, MD    00494315971358    mark.ellrichmann@uk-sh.de   
Principal Investigator: Annette Fritscher-Ravens, Prof. Dr.         
Sub-Investigator: Mark Ellrichmann, MD         
Sponsors and Collaborators
University of Schleswig-Holstein
Great Ormond Street Hospital for Children NHS Foundation Trust
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Annette Fritscher-Ravens, Prof. Dr. University Schleswig-Holstein
  More Information

No publications provided

Responsible Party: Mark Ellrichmann, Dr., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01692613     History of Changes
Other Study ID Numbers: A139/12
Study First Received: September 20, 2012
Last Updated: September 20, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 20, 2014