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Trial · Observational

Status unknownPhase not statedRegistry data

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

Short name MatchedQoL

NCTNCT04733066 (opens ClinicalTrials.gov in a new tab)Other idIIR-DE-002726
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase not stated
Enrollment
40 participants (estimated)
Sponsor
Charite University, Berlin, Germany · Other
Design
Not stated
Countries
1 country

Germany

Start
1 Sept 2020
Primary completion
Sept 2021 (estimated)
Completion
Sept 2022 (estimated)
First posted
1 Feb 2021
Last update posted
1 Feb 2021
Conditions
Short Bowel Syndrome · Intestinal Failure

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023
  1. Ph –

    MatchedQoL

    NCT04733066

    1 Sept 2020 to est. Sept 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeduglutideDrug

Arms2

  • Other

    Non-treatment Group

    1. Quality of life assessment (SBS-QoL, SF- 36) 2. Nutrition status assessment (BIA, BMI) 3. Assessment of functional absorptive small bowel length (citrulline) 4. Clinical data (nutritional program, stool characteristics)

  • Other

    Teduglutide-treated Group

    1. Quality of life assessment (SBS-QoL, SF- 36) 2. Nutrition status assessment (BIA, BMI) 3. Assessment of functional absorptive small bowel length (citrulline) 4. Clinical data (nutritional program, stool characteristics)

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. changes in QoL data during teduglutide therapy

    Time frame · through study completion, an average of 1 year

    Registry description

    SBS-QoL, SF-36

  2. changes in QoL data of patients without teduglutide therapy

    Time frame · through study completion, an average of 1 year

    Registry description

    SBS-QoL, SF-36

  3. changes in QoL data of teduglutide treated patients compared to changes in pairwise matched controls

    Time frame · through study completion, an average of 1 year

    Registry description

    SBS-QoL, SF-36

Secondary outcomes(7)

  1. BMI in kg/m^2

    Time frame · through study completion, an average of 1 year

    Registry description

    weight and height will be combined to report BMI in kg/m\^2

  2. Body cell mass in kg

    Time frame · through study completion, an average of 1 year

    Registry description

    measured by bioelectrical impedance analysis

  3. citrulline levels

    Time frame · through study completion, an average of 1 year

  4. stool characteristics by bristol stool scale

    Time frame · through study completion, an average of 1 year

    Registry description

    seven types of stool from 1 (hard lumps) till 7 (watery)

  5. parenteral support frequency

    Time frame · through study completion, an average of 1 year

  6. parenteral support volume

    Time frame · through study completion, an average of 1 year

  7. parenteral support calories

    Time frame · through study completion, an average of 1 year

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2020

4 results

Impact of Teduglutide on Quality of Life Among Patients With Short Bowel Syndrome and Intestinal Failure.

Chen et al. 2020JPEN. Journal of parenteral and enteral nutritioncited by 48

PMID 31006876PMC7004164DOI 10.1002/jpen.1588PUB-31006876

Free to read · publisher termsCC BY-NC4 results
Read at sourceSee results (4)

Indexing hint: Randomized controlled trial · 2013

6 results

Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide--analyses from a randomised, placebo-controlled study.

Jeppesen et al. 2013Clinical nutrition (Edinburgh, Scotland)cited by 79

PMID 23587733DOI 10.1016/j.clnu.2013.03.016PUB-23587733

Full text at the publisher6 results
Publisher pageSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Criteria: * teduglutide stop before study initiation * refusal or withdrawal of consent

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