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

Phase 3

Terminated

• Conditions: Rectal Cancer; Ulcerative Colitis; Short Bowel Syndrome
• Interventions: Drug: Placebo; Drug: Loperamide

• Registration Number: NCT02266849
• Lead Sponsor: Odense University Hospital

Brief 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

Detailed Description

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:

* 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

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.

* During hospitalization in connection to their operation at The Department of Surgery, University Hospital Odense. The patients are offered inclusion into the study either before or after surgery depending upon the clinical situation. For those who consent and fulfills the inclusion criteria, the study starts up on 7th day after surgery.

* Through their regular controls in the stoma clinic.

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-13
• Study First Posted: 2014-10-17
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-09
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

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Exclusion Criteria

• Complications associated with surgery
• Non-radical surgery
• Chemotherapy
• Poor compliance
• Other serious illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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
Loperamide	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

Primary Outcome Measures

Name	Time	Method
Output weight	2 days	Collection af output for two days to compare between the two periods

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal transit time	10 hours	Patients swallow a pill with radiopaque markers and collect stoma output every two hours

Trial Locations

Locations (1)

Odense University Hospital, Surgical Department A; 🇩🇰 Odense, Denmark