Ileostomy - Stoma
Conditions
Brief summary
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
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.
Interventions
DRUGTeduglutide
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.
DRUGPlacebo
Placebo
Sponsors
Shire
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The drug will be delivered to the patient according to the randomization scheme and neither the patient nor the investigators will know which patient is randomized into which group until the study is completed. Only the pharmacist at the AHN pharmacy will know the patient assigned to each group.
Intervention model description
Study subjects will be randomized to Teduglutide or placebo arm in a 1:1 allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in daily 24 hr ileostomy collection | Change from time of surgery to 12 weeks | (mL/day) |
Countries
United States
Outcome results
None listed