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

October 9, 2016 updated by: Niels Qvist, Odense University Hospital

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital, surgical department A

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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: Loperamide
12 mg Loperamide each day for three days
Other Names:
  • Imodium
Placebo Comparator: 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
Drug: Placebo
6 tablets daily for three days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Output weight
Time Frame: 2 days
Collection af output for two days to compare between the two periods
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal transit time
Time Frame: 10 hours
Patients swallow a pill with radiopaque markers and collect stoma output every two hours
10 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient evaluation
Time Frame: 14 days
Patients evaluation on when they received Loperamide and Placebo at the end of the collecting period
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Study Director: Niels Qvist, MD, DMsc, Odense University Hospital, Department of Surgery A, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 13, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 9, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s-20140081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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