Overview

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

Status:
Not yet recruiting
Trial end date:
2023-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allegheny Singer Research Institute
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborator:
Shire
Treatments:
Teduglutide
Criteria
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