Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study

• Status: Terminated
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide opposite Placebo.

Loperamide will be evaluated in relation to the following parameters

• Change in ileostomy output in g/day in relation to oral intake

• Quantification of the change in intestinal transit time using a radiopaque marker

• The patient´s own assessment on which period they received Loperamide or Placebo

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Treatments: Antidiarrheals; Loperamide

Criteria

Inclusion Criteria:

• Operation for rectal cancer or ulcerative colitis an ileostomy (loop or end ileostomy within the last 7 days) OR

• ileostomy patient with contact to the stoma clinic OR

• Short bowel syndrome with a permanent ileostomy

• signed consent form

Exclusion Criteria:

• Complications associated with surgery

• Non-radical surgery

• Chemotherapy

• Poor compliance

• Other serious illness