The Acute Effect of Loperamide on Ileostomy Output: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Study

Abstract

High stoma output is a common problem in patients with ileostomy and can lead to dehydration and electrolyte disturbances. The first drug of choice to reduce stoma output is often loperamide. The aim was to assess the acute effect of loperamide on (a) ileostomy output in g/day, (b) gastrointestinal transit time and (c) patient-reported effects. A total of 12 patients completed this double-blinded, randomized, placebo-controlled, crossover study, consisting of a 3-day treatment period with loperamide 12 mg/day or placebo followed by the reverse after a washout period of 5–7 days. Patients collected stoma output and noted food and fluid intake over 48 hr and swallowed a capsule with radiopaque markers for the determination of gastrointestinal transit time over 24 hr. At the end of the study, patients were asked to report their treatment sequence. Ileostomy output was significantly reduced during loperamide treatment (p < 0.02) with a median of 16.5% (range −5% to 46%). Transit time was reduced significantly for the passage of 10% of the markers (p = 0.02), but not for 50% and 100% of the markers. Fifty-eight per cent (N = 7) of the patients reported the correct treatment sequence (p = 0.41). Loperamide 12 mg/day reduced ileostomy output statistically significantly, but with varying effects among patients and without reaching the clinical significance of 20% set-up by this study. Dose–response studies should be performed, and standard treatment doses of loperamide should be reassessed. The study was registered at ClinicalTrials.gov – NCT02266849.