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Sponsored by: |
Given Imaging Ltd. |
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Information provided by: | Given Imaging Ltd. |
ClinicalTrials.gov Identifier: | NCT00555737 |
The purpose of this study is to determine how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients.
Condition | Intervention |
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Celiac Disease |
Device: Capsule Endoscopy |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy |
Enrollment: | 102 |
Study Start Date: | November 2003 |
Study Completion Date: | July 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 values:
Exclusion Criteria:
United States, Massachusetts | |
University of Massachusetts Memorial Medical Center | |
Worcester, Massachusetts, United States, 01655 | |
Finland | |
University of Tampere Medical School | |
Tampere, Finland | |
Italy | |
Universita Cattolica del Sacro Cuore | |
Rome, Italy | |
San Giovanni A.S. Hospital | |
Torino, Italy | |
Ospedale Maggiore - Policlinico | |
Milano, Italy, 20122 |
Principal Investigator: | Roberto de Franchis, MD, Prof. | Ospedale Maggiore - Policlinico, Milano, Italy |
Study ID Numbers: | MA-23 |
Study First Received: | November 8, 2007 |
Last Updated: | November 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00555737 |
Health Authority: | Italy: Ethics Committee |
Celiac Disease Capsule Endoscopy small Bowel Disease |
Metabolic Diseases Digestive System Diseases Gastrointestinal Diseases Malabsorption Syndromes |
Celiac Disease Metabolic disorder Intestinal Diseases |