PillCam SBC System Functionality in Established and Suspected IBD Patients

Exclusion Criteria

• •Antibiotic Associated Colitis
• •Stool positive for Ova \&Parasite and for Clostridium difficile toxin within 3 months of enrollment
• •Other known infectious cause of symptoms
• •Known or suspected intestinal obstruction
• •Non-steroidal anti-inflammatory drugs (twice weekly or more) during the 4 weeks preceding enrollment.
• •Suspected or known GI stricture, followed by patency capsule study or other imaging study that could not prove patency of the GI tract
• •Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule
• •Patient with known gastrointestinal motility disorders
• •Subjects with known or suspected delayed gastric emptying
• •Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions
• •Patient has any allergy or other known contraindication or intolerance to the medications used in the study
• •Patient has any condition, which precludes compliance with study and/or device instructions
• •Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception
• •Concurrent participation in another clinical trial using any investigational drug or device
• •Patient suffers from a life threatening condition
• •Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters