PillCam SBC System Functionality in Established and Suspected IBD Patients (PIANO)

This is an interventional diagnostic trial for Chronic Inflammatory Small Bowel Disease Read More

Inclusion criteria:

• Patients ages 18-75 years, inclusive
• Patient has known crohn disease and/ or ulcerative colitis Or
• Patient suspected to have inflammatory bowel disease and suffers from either:
• Diarrhea for more than 6 weeks and/or
• Abdominal pain for more than 6 weeks and/or
• Extra-luminal manifestations of IBD including: erythema nodosum, pyoderma gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis and

• Suffers from at least one of the symptoms / lab abnormalities listed below:

  • Positive inflammatory marker (ESR, C reactive protein (CRP), thrombocytosis, fecal lactoferrin, fecal calprotectin) within 3 months prior to enrollment
  • Unexplained anemia (less than normal limits) within 3 months prior to enrollment
  • Hypoalbuminemia (<3.5 g/dl) within 3 months of enrollment
  • Positive IBD serology within 3 months of enrollment
  • Recurrent Fevers
  • Unexplained weight loss
  • Gastro-intestinal bleeding including melena and/or hematochezia and/or fecal occult blood test (FOBT) positive.
  • Chronic perianal disease (fistula, fissure, peri-rectal abscess)
  • Abnormal imaging of Gastrointestinal (GI) tract (e.g. Magnetic resonance enterography (MRE)) suggestive of inflammatory bowel disease
• For known CD patients, proven patency by the patency capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE performed within the 90 days prior to enrollment
• Patients agree to sign consent form

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