Clinical trial NCT03953170: Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
Official title: Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Ileostomy - Stoma
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2019-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study subjects will be randomized to Teduglutide or placebo arm in a 1:1 allocation.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in daily 24 hr ileostomy collection
timeFrame: Change from time of surgery to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: Allegheny Health Network
name: James McCormick, DO
role: PRINCIPAL_INVESTIGATOR
References: