Endomicroscopy, IBS and Food Intolerance
Condition: Endomicroscopy; Inflammatory Bowel Syndrome; Food Intolerance
MeSH terms: Syndrome; Food Intolerance
Study type: Observational

Summary: 
      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.
    

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.
    

Observational model: Case-Control
Time perspective: Prospective
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
      
Biospecimen description: 
      -  duodenal biopsies

        -  duodenal fluid