NCT00555737

Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23)

Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 102 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients.

Detailed description

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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DEVICE	Capsule Endoscopy	Given® Diagnostic system with Pillcam SB

Timeline

• Start date: 2003-11-01
• Completion: 2007-07-01
• First posted: 2007-11-09
• Last updated: 2019-07-31

Locations

5 sites across 3 countries: United States, Finland, Italy