Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

Study Overview
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Brief Summary
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The objective of the study is to investigate the natural history of patients with a temporary ileostomy and to assess the effect of Teduglutide in reducing morbidity, hospital readmissions and post reversal complications.

Detailed Description
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This is a prospective, controlled, randomized, double blind study. A total of 36 subjects will be enrolled into the study. Subjects will be randomized to receive Teduglutide or Placebo for 12 weeks or until the ileostomy is reversed. Teduglutide or placebo will be administered via a daily subcutaneous injection into the abdomen or thigh. The sites will be rotated with each injection. If adverse effects develop the subjects will be permitted to hold drug administration for a maximum of 5 days in total during the 12-week study.

Official Title
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Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Drug: Teduglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are undergoing temporary ileostomy (loop or end ileostomy) regardless of the indication or technique used (open or laparoscopy) as part of their regular standard of care Age- 18-80 years old Normal routine laboratories (CMP, CBC, CRP, amylase, lipase) Permitted medications will include biologicals which dose has not been changed for > 6 months, and immunosuppressant therapy which dose has not been changed for 3 months (i.e. codeine sulfate, loperamide, or Lomotil) Exclusion Criteria: Emergency need for ileostomy Pregnant or nursing Malnutrition or requiring parenteral or enteral nutrition Known intestinal obstruction, stricture, or adhesions that would predispose the patient to the development of intestinal obstruction, perforation, hemorrhage, or intestinal abscess Intestinal fistulas or abscess proximal to the ostomy Small bowel resection greater than 50 cm. Clinically significant cardiovascular, renal, pulmonary, endocrine, immunologic, dermatology, neurological or psychiatric disorders Cholelithiasis or pancreatitis Family history of colorectal cancer or familial polyposis Cancer in the last 5 years History of HIV, Hepatitis B or C, or other acute systemic or intestinal infections requiring antibiotics Use of GLP1 analogues which may increase the risk of acute pancreatitis Treatment of Octreotide

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study subjects will be randomized to Teduglutide or placebo arm in a 1:1 allocation.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Teduglutide<br>Teduglutide 0.05 g/kg/day | Drug: Teduglutide<br>* Teduglutide (Gattex, Shire) was approved by the FDA in 2012 for use in adult patients with short bowel syndrome requiring parenteral support only. The results of this study will not be used to justify a change of indication, or dose currently approved for Teduglutide, and will not be used to advertise the drug. This study meets all of the requirements for exemption from the IND regulations and an IND exemption has been confirmed by the FDA.<br>* Other names: Gattex;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily 24 hr ileostomy collection | (mL/day) | Change from time of surgery to 12 weeks |