Short summary

Patients included in the study all go through two collecting periods. They are randomized to start with either Loperamide or placebo followed by a sequence with the opposite drug. The patient will be blinded according to randomization.

The aim of the study is to assess the effect of Loperamide against Placebo on following parameters:

• Change in ileostomy output in g/day in relation to intake.
• Quantification of the change in transit time using a radiopaque marker.

Rationale

Loperamide is a drug often used every day by the many ileostomy patients. The quality of studies on the effect preformed in the past is not optimal and clinical experience regarding the efficacy is questionable. Based on this background, we find it highly relevant to examine the effect further, in larger populations than before, in order to optimize the treatment of patients with ileostomy, temporary as well as permanent.

Description of the cohort

The study includes three types of patients: Patients operated for rectal cancer or ulcerative colitis with a temporary or permanent ileostomy, and patients with short bowel syndrome with a permanent ileostomy. The patients are recruited through outpatient clinic at Department of Surgery and Department of Gastroenterology, and patients currently in the hospital in relation to their stoma operation.

Data and biological material

Stoma output is collected over two periods of two days. Output is weighed.

The patients weigh all intakes in the two periods.

Transit time is registered by using a radiopaque marker. Stoma output is collected and x-rayed to quantify transit time.

Collaborating researchers and departments

Department of Surgical Gastroenterology, Paediatrics and Endocrinology, Odense University Hospital

• Professor and Consultant Niels Qvist, DMSc
• Pre-graduate Research Student Katrine Poulsen, Medical Student

Department of Medical Gastroenterology, Odense University Hospital

• Clinical Associate Professor Jens Kjeldsen, PhD