Capsule Endoscopy in Cystic Fibrosis
Capsule Endoscopy in Cystic Fibrosis
Cystic Fibrosis patients continue to have bowel problems even after adequate pancreatic
 enzyme supplementation. There may be pathology of the lining of the bowel. Capsule endoscopy
 will be used to photograph the entire bowel.
The capsule endoscope system (Given Imaging, Ltd.) consists of 3 elements: a disposable
 capsule (PillCamTM SB) that acquires video images during natural propulsion through the
 digestive system.

 The video-capsule PillCamTM SB has been cleared by the FDA for use in patients over 10 years
 of age for the detection of small intestinal disorders. It has been used in patients under
 age 10 and has been placed with the use of a gastroscope in patients unable to swallow the
 capsule. In fact, a new delivery device has been introduced recently that facilitates
 placement of the video-capsule in pediatric patients.For the purposes of this study, only
 patients over age 10 years who are able to swallow the capsule would be enrolled.

 There are approximately 450 CF patients in the registry in Israel, with about 300 above the
 age of 10. Study subjects would be enrolled from this registry population and would be
 screened for the presence of the contraindications noted above. Patients would be assessed
 for symptoms of possible small bowel lesions at the time of enrollment including
 gastrointestinal bleeding, palpable abdominal mass, weight loss, diarrhea, and abdominal
 pain. Markers of inflammation including stool calprotectin will be assessed in all patients.
 These data would be recorded for further analysis.

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Inclusion Criteria:

 Inclusion criteria would include those subjects with known CF who are able to give informed
 consent to undergo capsule endoscopy and whose guardians provide consent as well, if
 applicable. -

 Exclusion Criteria

 Subjects would be excluded if they were felt to be poor surgical candidates as patients may
 need to undergo surgery in the rare event of retention of the capsule. Patients genotype
 and lung function will be noted; patients will be excluded if FEV1 < 40%.

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