P-115 Single Dose Linaclotide for Capsule Endoscopy Preparation—A Pilot Study. (March 2016)

• Record Type: Journal Article
• Authors: Stein, Daniel; Copland, Andrew; Orton, Charles; McDaniel, Deborah; Hays, Rachel
• Is Part Of: Inflammatory bowel diseases. Volume 22(2016:Mar.)Supplement 1
• Publication Date: 2016-03
• Subjects: Inflammatory bowel diseases -- Periodicals; Colitis, Ulcerative -- Periodicals; Crohn Disease -- Periodicals; Inflammatory Bowel Diseases -- Periodicals; 616.344
• DOI: 10.1097/01.MIB.0000480219.15168.c3
• Languages: English
• ISSNs: 1078-0998

Abstract

Abstract : Background: Capsule endoscopy provides non-invasive visualization of the small bowel. In Crohn's disease, it supplements conventional endoscopy by delineating small bowel involvement and monitoring therapy response. Visualization is often limited, and slow transit of the capsule can mean an incomplete study if transit time exceeds battery life. We hypothesized that using linaclotide as preparation for capsule endoscopy would provide a better quality preparation and potentially reduce transit times due to its effect in increasing intestinal motility. We set to compare linaclotide to local standard of care with polyethylene glycol solution in a pilot to establish efficacy and safety. Methods: Using institutional funding, patients scheduled for capsule endoscopy were approached serially until 10 were enrolled as subjects. NPO status was maintained per routine, but in place of polyethylene glycol, subjects were given 290 μg of linaclotide one hour prior to endoscopy. Ten comparison subjects were selected at random from historic controls within the last year. All studies were then reviewed by a blinded gastroenterology attending and graded in terms of visualization quality (ideal, good, poor or very poor) and had small bowel transit time measured. Results: Twelve men and 8 women were included with average age of 61. Median small bowel transit was 198 (linaclotide) versus 182 (polyethylene glycol) minutes ( P = 0.24, t -test). Three studies (2 linaclotide and 1 polyethylene glycol) failed to image the complete small intestine, with 2 of those failing to leave the stomach; all of these were patients with known GERD or gastroparesis. Side effects of linaclotide were minimal: 3 subjects reported mild diarrhea, with one report of abdominal pain and headache. Endoscopy quality was rated as good or very good in 3/9 of linaclotide and 6/9 polyethylene glycol, without a significant difference ( P = 0.35, Fisher's exact). Conclusions: No safety concerns or decreased efficacy were identified with single dose linaclotide when compared to historic control with polyethylene glycol for use in capsule endoscopy. Study success was limited by poor gastric clearance in several subjects. A larger study powered to evaluate efficacy of this preparation is warranted.