Serum Markers in Gluten Challenge
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      1. The purpose of this research study is to evaluate non-invasive markers of celiac disease
           activity in subjects that are on a gluten-free diet, in remission from celiac disease
           who undergo gluten challenge.

        2. The secondary aims of this protocol are to identify novel mediators important in the
           pathophysiology of celiac disease and to evaluate changes in metabolism with gluten
           exposure.
    

Detailed description: 
      The diagnosis of celiac disease carries with it important ramifications. Celiac disease is a
      systemic immunologic disorder in which the sentinel lesion is an enteropathy triggered by
      polypeptides derived primarily from the gliadin proteins found in wheat, rye and barley.
      Ingestion of the offending proteins leads to inflammation and intestinal mucosal damage,
      which results in a spectrum of abdominal symptoms, increased intestinal permeability,
      malabsorption, occult gastrointestinal bleeding and diarrhea. Systemic manifestations of
      celiac disease include a myriad of conditions including malignancy and autoimmune disease.

      The only accepted treatment for celiac disease is lifelong adherence to a gluten free diet.
      Adherence to this diet, simply put avoiding all foods containing even small amounts of wheat,
      rye and barley, has been shown to lead to improvement in the majority of related problems and
      normalization of all standard diagnostic tests. Because of this many individuals who present
      for evaluation of possible celiac disease but who are already on a gluten free diet cannot be
      tested accurately as there is currently no way of differentiating between healthy individuals
      and individuals with well treated celiac disease. The standard practice in such cases is to
      perform a 'Gluten Challenge' whereby the patient eats the equivalent of 2 slices of bread per
      day for six to eight weeks before returning for evaluation with serologic testing and
      endoscopy with duodenal biopsy. The use of the gluten challenge in clinical practice is
      limited by patient symptoms and resistance to such a long test period, after which it may
      take a number of weeks for the intestine to heal and the symptoms to resolve. Autoantibodies
      to tissue transglutaminase or antibodies to deamidated gliadin, while being excellent tools
      to predict celiac disease in patients who have been on a long-term gluten containing diet,
      display low sensitivities to detect short-term and/or recent gluten exposure. For this
      reason, it would be very useful if novel circulating markers could be identified that
      indicate the presence of celiac disease and in particular would provide an early and less
      invasive marker of a positive response to gluten challenge.
    

Intervention name(s): Gluten; Gluten
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3g; 10g
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: celiac disease; gluten challenge