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.
- Patient age is 18 years or older
- Patient agrees to sign the Informed Consent Form
- Patient has positive celiac serology or negative celiac serology + IgA deficiency and
suffers from one or more of the following symptoms and/or abdominal biochemical
1. Chronic diarrhea
2. Weight loss
3. Abdominal cramps
4. History of spontaneous abortion
5. Iron deficiency anemia
9. Low cholesterol
10. Low prothrombin activity
- Patient is known or is suspected to suffer from intestinal obstruction.
- Patient has a cardiac pacemaker or other electro-medical device.
- Patient suffers from severe swallowing disorder or Zenker's diverticulum
- Patient has any condition, which precludes compliance with study and/or device
- Female patient is pregnant
- Patient suffers from life threatening conditions
- Patient is currently participating in another clinical study.
Roberto de Franchis, MD, Prof.
Ospedale Maggiore - Policlinico, Milano, Italy