MACCS: Multicenter Australian CE in Patients With Suspected Crohn's Disease Study

clinics

Inclusion Criteria:

• Patient will be 10 years and older
• Patient suffers from abdominal pain and/or diarrhea for the last 6 weeks and/or expresses extra-intestinal manifestations of CD

• Patient has at least one of the following over the preceding 6 months (plus symptoms suspicious of small bowel Crohn's Disease):

  • Positive inflammatory marker (ESR, CRP, thrombocytosis, leucocytosis, fecal lactoferrin, fecal α-1 antitrypsin)
  • Unexplained anemia,
  • Recurrent fever,
  • Weight loss (at least 10% of normal body weight in adults),
  • Hypoalbuminaemia (<3.5 g/dL),
  • Gastro-intestinal bleeding,
  • Chronic perianal disease (fistula, fissure),
  • Abnormal white cell scan
  • Positive ASCA
  • First degree relative of a person suffering from IBD (only for subjects without known IBD),

• Patient underwent standard evaluation that includes colonoscopy and attempted ileoscopy and also SBFT within six months prior to enrollment, which were non-diagnostic. Blood tests should have been done within one month of enrolment.

  • Patient or legal guardian agrees to sign the Informed Consent Form

Exclusion Criteria:

• Patients with indeterminate colitis where the purpose is only to make a definitive diagnosis and where the inclusion criteria are not otherwise met
• Patient is known to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting)
• Definite stricture seen on SBFT
• Patient had suspected GI stricture, a Given® Patency capsule was administered and Patient did not pass the Patency capsule.
• Patient has a pacemaker or other implanted electro-medical device
• Patient has known history of small bowel Crohn's disease
• Patient on treatment for active IBD
• Patient with suspected celiac disease that has not been excluded
• Patient on non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or higher) during the 3 months preceding enrolment
• Patient is pregnant
• Patient has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems
• Patient suffers from life threatening conditions
• Patient is currently participating in another clinical study that may directly or indirectly affect the results of this study