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

Ileostomy - Stoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03953170
Study type Interventional
Source Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Contact
Status Withdrawn
Phase Phase 3
Start date June 2, 2022
Completion date December 29, 2022
View Details
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