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

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555737
• Other study ID #: MA-23
• Status: Completed
• Start date: November 2003
• Est. completion date: July 2007

Study information

• Verified date: November 2007
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 values:

1. Chronic diarrhea

2. Weight loss

3. Abdominal cramps

4. History of spontaneous abortion

5. Iron deficiency anemia

6. Osteoporosis

7. Infertility

8. Hypoalbuminaemia

9. Low cholesterol

10. Low prothrombin activity

Exclusion Criteria:

• 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 instructions.

• Female patient is pregnant

• Patient suffers from life threatening conditions

• Patient is currently participating in another clinical study.

Related Conditions & MeSH terms

• Celiac Disease
• Intestinal Diseases

Intervention

Device:
• Capsule Endoscopy
Given® Diagnostic system with Pillcam SB

Locations

Country	Name	City	State
Finland	University of Tampere Medical School	Tampere
Italy	Ospedale Maggiore - Policlinico	Milano
Italy	Universita Cattolica del Sacro Cuore	Rome
Italy	San Giovanni A.S. Hospital	Torino
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  Finland,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of findings identified during the capsule endoscopy or upper GI endoscopy procedure, and which were considered by the investigator as related to the gluten sensitive enteropathy origin		within 14 days of enrollment
Secondary	Longitudinal extent of villous changes in the small bowel will be evaluated.		within 14 days of enrollment