Background and study aims: SmartPill(®) (Given Imaging Corp.,Yoqneam,Israel) is an ingestible, non-imaging capsule that records physiological data including contractions and pH throughout the gastrointestinal tract. There are scarce data looking at SmartPill(®) assessment of patients with known/suspected small-bowel Crohn's Disease (CD). This pilot study aims to investigate feasibility and safety of SmartPill(®) to assess gut motility in this group.
Patients and methods: Over 1 year, patients with known/suspected CD, referred for small-bowel capsule endoscopy (SBCE), were invited to participate and 12 were recruited (7 female, 5 male, mean age 44.2 ± 16.6 years). They underwent hydrogen breath test to exclude small-bowel bacterial overgrowth, patency capsule (Agile(®)), and provided stool samples for fecal calprotectin (FC). Patients ingested PillCam(®)SB2 and SmartPill(®) 4 hours apart. Using unpublished data, 33 healthy controls also were identified for the study. P < 0.05 was considered statistically significant.
Results: Of the 12 patients enrolled, 10 underwent complete Smartpill(®) examination (1 stomach retention, 1 dropout). Pillcam(®) was complete in 10 (1 dropout, 1 stomach retention). Mean fecal calprotectin was 340 ± 307.71 mcg/g. The study group had longer transit times and lower gut motility index than did the controls. The difference in motility appears to be statistically significant (P < 0.05). Longer transit times for SmartPill(®) (not statistically significant) may have been due to different specifications between the capsules. Limitations included transient Smartpill(®) signal loss (5/10 studies).
Conclusions: This is the first pilot to attempt combining SBCE and SmartPill(®) to assess small-bowel CD. Data on motility in CD are scarce. Multimodal information can provide a clearer clinical picture. Despite concerns about capsule retention in CD patients, SmartPill(®) seems safe for use if a patency capsule is employed beforehand.