Clinical Trial: Teduglutide for Enterocutaneous Fistula (ECF)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Teduglutide for Treatment of Enterocutaneous Fistula (ECF) - a Pilot Study to Demonstrate Safety and Feasibility

Brief Summary: The purpose of this study is to determine whether teduglutide is safe and feasible to be given for the treatment of enterocutaneous fistula (ECF). We hypothesize that the drug will be well-tolerated and will improve the volume of daily ECF output as well as improve the functional quality of life.

Detailed Summary: Eligible patients will be initially randomly assigned to either daily subcutaneous teduglutide injections (0.05 mg/kg/d) for 8 weeks or continued standard of care for 8 weeks. After 8 weeks, the groups will cross over.
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Efficacy [ Time Frame: 2 months of treatment ]

Decrease in average 3-day fistula volume by 20% from baseline


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cessation of fistula output [ Time Frame: 2 months of treatment ]
    Complete healing of fistula
  • Health-related quality of life [ Time Frame: 56 days, 112 days, and 3 months after end of treatment ]
    Health-related quality of life will be assessed using the Short Bowel Syndrome Quality of Life, a validated questionnaire


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: August 31, 2016
Date Started: January 2017
Date Completion: July 2018
Last Updated: September 23, 2016
Last Verified: September 2016