NCT04857801

Brief Summary

A retrospective analysis was performed using data of patients suffering from non-malignant SBS-IF. They were treated with teduglutide in a multidisciplinary SBS-IF program at a single university medical center between June 2016 and June 2020.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

April 19, 2021

Last Update Submit

April 22, 2021

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • enteral autonomy

    percentage of patients reaching complete discontinuation of parenteral support

    at least 6 months of teduglutide treatment

Interventions

TeduglutideDRUG

effect of teduglutide on intestinal rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

SBS-IF patients receiving teduglutide for at least 6 months

You may qualify if:

  • SBS-IF

You may not qualify if:

  • \< 18 years
  • Incompliance
  • \< 6 months of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

teduglutide

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 23, 2021

Study Start

June 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share