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

Teduglutide

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.

2022-06-02

2022-11-25

2022-12-29

Withdrawn

Early phase I

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

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2023-02-23