A Phase 3 interventional study of Loperamide and Placebo in Rectal Cancer, Ulcerative Colitis and Short Bowel Syndrome, sponsored by Odense University Hospital. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-11.
Sponsored by Odense University Hospital · Phase 3, Interventional, and Treatment
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
The aim of this study is to quantify the effect of Loperamide on ileostomy output in patients operated for rectal cancer, ulcerative colitis and in patients with short bowl syndrome. These patients are recruited through The Department of Surgery and The Department of Gastroenterology, University Hospital Odense. The effect of Loperamide will be evaluated against Placebo in relation to the following parameters:
Construction of a stoma is a frequently used part of the surgical treatment of intestinal cancer and chronic intestinal inflammation. More than 60% of patients with an ileostomy develop dehydration and loss of salts and minerals, due to an excessive stoma output. The most common method used to reduce stoma output is Imodium® ( Loperamide ). The effect has never been studied extensively, probably because it is an over the counter medicine. The treatment is relatively expensive and also subject to side effects, even if they are mild. Therefore, the investigators found it relevant to perform a clinical study to determine the effect. The results will be important for future patient treatment.
The study is a clinical blinded randomized crossover study. 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 first two types of patients will be recruited through two ways.
Patients with short bowel syndrome are offered inclusion through their contact with The Department of Gastroenterology, University Hospital Odense, if they meet the criteria for inclusion.
Patients will undergo to periods during the study. They will be randomized to start with either Loperamide or Placebo. Each period consists of 3 days.
Day 1 - Uploading of the drug
Day 2 - Collecting of stoma output when necessary
Day 3 - Radiopaque marker and collection of stoma output every two hours
After 7 days without medicine intake the patient starts the second period with the opposite drug.
During day 2-3 the patient will register and weigh all food and fluid intake.
149 studies on the registry are indexed under Short Bowel Syndrome; 25 are open to participants now.
This study's enrollment of 12 is below the median of 20 across 100 interventional studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
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Exclusion Criteria:
Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours
Drug: Loperamide
Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours
Drug: Placebo
12 mg Loperamide each day for three days
Also known as: Imodium
6 tablets daily for three days
Output weight
Collection af output for two days to compare between the two periods
Time frame: 2 days
Gastrointestinal transit time
Patients swallow a pill with radiopaque markers and collect stoma output every two hours
Time frame: 10 hours
Patient evaluation
Patients evaluation on when they received Loperamide and Placebo at the end of the collecting period
Time frame: 14 days
This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Odense University Hospital