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NCT Number: NCT01990040

Registry for Participants With Short Bowel Syndrome

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Sex eligibility

All sexes

Study type

Observational

Primary location

Shire

Lexington, Massachusetts, 02421, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female participants, of any age, with a diagnosis of short bowel syndrome (SBS).
  • Signed informed consent and medical records release by the participant or a legally acceptable representative
  • 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

  • Participants currently participating in a blinded clinical trial or their extension studies.
  • Participants who have never been on PN/IV support.
  • Participants who are currently or previously exposed to any Glucagon-like peptide 2 (GLP-2) analogs other than teduglutide.

Treatment and study plan

Primary outcomes

  1. Occurrence of Colorectal Cancer in Short Bowel Syndrome (SBS) Participants With a Remnant Colon Currently Being Treated With or Ever Having Been Treated With Teduglutide

    Time frame: 10 years

    Incidence rates of colorectal cancer in participants will be calculated by dividing the number of incident colorectal cancer cases by the total number of person-years observed since beginning treatment with teduglutide.

Secondary outcomes

  1. Occurrence of Other Malignancy

    Time frame: 10 years

    Incidence rates of other malignancies will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  2. Occurrence of Benign Neoplasia of the Gastrointestinal (GI) tract, Hepatobiliary System, and Pancreas in Participants

    Time frame: 10 years

    Incidence rates of benign neoplasia of the GI tract, hepatobiliary system, and pancreas will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  3. Occurrence of Colorectal Polyps

    Time frame: 10 years

    Incidence rates of colorectal polyps will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  4. Occurrence of Intestinal Obstruction

    Time frame: 10 years

    Incidence rates of intestinal obstruction will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  5. Occurrence of Pancreatic and Biliary Disease

    Time frame: 10 years

    Incidence rates of pancreatic and biliary disease will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  6. Occurrence of Heart Failure and Other Manifestations of Volume Overload

    Time frame: 10 years

    Incidence rates of heart failure and other manifestations of volume overload will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  7. Occurrence of Allergic/Hypersensitivity Reaction to Teduglutide

    Time frame: 10 years

    Incidence rates of allergic/hypersensitivity reactions to teduglutide will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  8. Occurrence of Other Adverse Events (AEs) Potentially Related to Treatment with Teduglutide

    Time frame: 10 years

    Incidence rates of other AEs will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. Incidence rates of other AEs will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product (ICH Guidance E2A 1995). This includes an exacerbation of a pre-existing condition.

  9. Actual Volume Change in Parenteral Support (PS)

    Time frame: 10 years

    PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.

  10. Percentage Volume Change in Parenteral Support (PS)

    Time frame: 10 years

    PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.

  11. Actual Change in the Number of Days per Week on Parenteral Support (PS)

    Time frame: 10 years

    PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.

  12. Percentage Change in the Number of Days per Week on Parenteral Support (PS)

    Time frame: 10 years

    PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.

  13. Percent of Participants Weaning From Parental Support (PS)

    Time frame: 10 years

    PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Collaborators

  • Takeda Development Center Americas, Inc.

Registry information

Official study title

A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome

Important dates

Study start
2014
Primary completion
2032
Study completion
2032
First posted
Nov 21, 2013
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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