Celiac Disease Clinical Trial
Official title:
Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy
The purpose of this study is to determine how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients.
Gluten-sensitive enteropathy (GSE), also known as celiac disease, is characterized by
abnormal small intestinal mucosa arising as a consequence of an inappropriate inflammatory
response to ingested gluten in susceptible individuals.
These changes cause a loss of absorptive capacity which in turn leads to variable degrees of
malabsorption. A person suffering from celiac may have symptoms ranging from mild iron
deficiency anemia to severe diarrhea and weight loss. Characteristically, removal of gluten
from the diet is followed by resolution of the mucosal changes and the symptoms.
Celiac disease is suspected on the basis of clinical signs and symptoms, and is generally
confirmed by serological testing and small bowel biopsy. Patients with suspected celiac
disease undergo upper GI endoscopy with mucosal biopsy of the duodenum, in order to detect
the characteristic histological changes.
Although the main role for endoscopy in GSE is to obtain tissue for histological examination,
a variety of endoscopic changes have been described in these patients,such as nodularity of
the mucosa and 'scalloping' or loss of the duodenal mucosal folds.
The Given® Diagnostic System can visually investigate the small bowel, producing high-quality
images of the mucosa, which might be able to detect villous atrophy and thus could be used in
the assessment of patients with GSE. Whereas upper GI endoscopy is invasive, often requires
sedation and may be uncomfortable, Capsule Endoscopy is less invasive, convenient to use and
does not require sedation.
Capsule Endoscopy could become an important tool for the non-invasive assessment of small
bowel mucosa in GSE.
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