Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT00434551
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT00434551
Study Brief:
Protocol Section:
NCT00434551