Clinical Trials Study
N/A
Registry for Participants With Short Bowel Syndrome
Conditions: SHORT BOWEL SYNDROME
- Study #:
- NCT01990040
- Last Updated:
- 10/10/2025
- Recruitment Status:
- Active, not recruiting
- Estimated Study Completion Date:
- 06/30/2032
Summary
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in participants with SBS. SBS participants treated and not treated with teduglutide will be enrolled.
Age: All ages
Gender: All
Start Date: 06/23/2014
Primary Completion Date (Estimated): 06/30/2032
Study Completion Date (Estimated): 06/30/2032
Accepts Healthy Volunteers: No
Trial Purpose and Description
Eligibility Criteria
Age: All ages
Gender: All
Accepts Healthy Volunteers: No
Inclusion criteria:
1. Male and female participants, of any age, with a diagnosis of short bowel syndrome (SBS).
2. Signed informed consent and medical records release by the participant or a legally acceptable representative
3. Participants who have never received teduglutide treatment must be on parenteral nutrition (PN)/intravenous (IV) fluids support for at least 6 months at the time of enrollment.
Exclusion criteria:
1. Participants currently participating in a blinded clinical trial or their extension studies.
2. Participants who have never been on PN/IV support.
3. Participants who are currently or previously exposed to any Glucagon-like peptide 2 (GLP-2) analogs other than teduglutide.
Principal Investigator
John Thompson, MD