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

Allegheny Health Network (AHN)

Status and phase

Withdrawn

Phase 3

Conditions

Ileostomy - Stoma

Treatments

Drug: Teduglutide

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03953170

Teduglutide

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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