Status:

UNKNOWN

Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis

Lead Sponsor:

Charite University, Berlin, Germany

Collaborating Sponsors:

Takeda

Conditions:

Short Bowel Syndrome

Intestinal Failure

Eligibility:

All Genders

18+ years

Brief Summary

The aim of this prospective longitudinal study is to compare the quality of life of short bowel patients prior to and on teduglutide treatment with a non-treated patient group in a matched-pair design...

Detailed Description

Short bowel syndrome (SBS) is a malabsorptive disorder mostly caused by surgical interventions, which may result in chronic intestinal failure (cIF). The incidence is progressively increasing due to m...

Eligibility Criteria

Inclusion

  • SBS-associated adult chronic IF with parenteral nutritional support
  • previous inclusion in the PNLiver trial with existing SF-36 and SBSQoL data
  • signed informed consent

Exclusion

  • teduglutide stop before study initiation
  • refusal or withdrawal of consent

Key Trial Info

Start Date :

September 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2022

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04733066

Start Date

September 1 2020

End Date

September 1 2022

Last Update

February 1 2021

Active Locations (1)

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Charite University, Berlin, Germany

Berlin, Germany, 10117