Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy

Completed

• Conditions: Systemic Sclerosis

• Registration Number: NCT00958672
• Lead Sponsor: University Hospital, Rouen

Brief Summary

The aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. The investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-17
• Study Start: 2009-08
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Written informed consent
• Systemic sclerosis based on the ACR diagnostic criteria

Exclusion Criteria

• Patients with other connective tissue diseases
• Pregnancy
• Absence of contraception in women
• Patients with pace maker
• Patients with intestinal pseudo-obstruction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis	1 year

Secondary Outcome Measures

Name	Time	Method
- to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms	1 year
to assess a correlation between small intestinal mucosal abnormalities and nutritional status	1 year
to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis	1 year

Trial Locations

Locations (1)

CHU-Rouen; 🇫🇷 Rouen, France