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Study · Non-randomized trial · n = 87 · 2023

3 results

Effects of Teduglutide on Diarrhea in Pediatric Patients with Short Bowel Syndrome-Associated Intestinal Failure.

Fifi A, Raphael BP, Terreri B, Uddin S, Kaufman SS

Journal of pediatric gastroenterology and nutrition22 Aug 2023Cited by 5 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In children receiving teduglutide, BSFS scores changed by -1.8 and -2.2 from baseline at weeks 12 and 24, respectively.

    In plain wordsIn children receiving teduglutide, stool consistency scores decreased from baseline at weeks 12 and 24.

    Outcome
    DecreaseBSFS score at weeks 12 and 24
    Study

    n = 87

    Analysis
    Primary
    Outcome group
    Stool Consistency · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    BSFS change
    −1.8 points
    week 12
    SE
    0.26 points
    week 12
    BSFS change
    −2.2 points
    week 24
    SE
    0.27 points
    week 24

    Source sentences

    Summary
    Among the total teduglutide group (n = 87), there were significant changes from baseline to weeks 12 and 24 in mean (standard error) Bristol Stool Form Scale (BSFS) score [-1.8 (0.26; P < 0.0001) and -2.2 (0.27; P < 0.0001), respectively]
    2 context sentences
    Summary · context
    Data from 2 open-label, multicenter, phase 3 pediatric SBS-IF clinical trials of teduglutide (NCT01952080 and NCT02682381) were pooled where possible.
    Summary · context
    The primary objective was to evaluate the change in stool consistency, frequency, and volume from baseline to weeks 12 and 24 of treatment in patients who received any teduglutide dose from both studies ("total teduglutide").
  2. 02HumanNon-randomized trialEfficacy outcome

    In children receiving teduglutide, PN/IV volume changed by -16.9 and -20.1 mL/kg/day from baseline at weeks 12 and 24, respectively.

    In plain wordsIn children receiving teduglutide, intravenous support volume decreased from baseline at weeks 12 and 24.

    Outcome
    DecreasePN/IV volume at weeks 12 and 24
    Study

    n = 87

    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    PN/IV change
    −16.9 mL/kg/day
    week 12
    SE
    1.7 mL/kg/day
    week 12
    PN/IV change
    −20.1 mL/kg/day
    week 24
    SE
    2.3 mL/kg/day
    week 24

    Source sentences

    Summary
    parenteral nutrition and/or intravenous fluid (PN/IV) volume [-16.9 (1.7; P < 0.0001) and -20.1 (2.3; P < 0.0001) mL/kg/day, respectively]
    2 context sentences
    Summary · context
    Data from 2 open-label, multicenter, phase 3 pediatric SBS-IF clinical trials of teduglutide (NCT01952080 and NCT02682381) were pooled where possible.
    Summary · context
    The primary objective was to evaluate the change in stool consistency, frequency, and volume from baseline to weeks 12 and 24 of treatment in patients who received any teduglutide dose from both studies ("total teduglutide").
  3. 03HumanNon-randomized trialEfficacy outcome

    In children receiving teduglutide, enteral nutrition increased by 9.2 and 9.6 mL/kg/day at weeks 12 and 24, respectively.

    In plain wordsIn children receiving teduglutide, gut-delivered nutrition increased from baseline at weeks 12 and 24.

    Outcome
    IncreaseEnteral nutrition at weeks 12 and 24
    Study

    n = 87

    Outcome group
    Enteral Nutrition · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Enteral volume change
    9.2 mL/kg/day
    week 12
    SE
    1.7 mL/kg/day
    week 12
    Enteral volume change
    9.6 mL/kg/day
    week 24
    SE
    2.3 mL/kg/day
    week 24

    Source sentences

    Summary
    and enteral nutrition volume [9.2 (1.7; P < 0.0001) and 9.6 (2.3; P = 0.0002) mL/kg/day, respectively].
    2 context sentences
    Summary · context
    Data from 2 open-label, multicenter, phase 3 pediatric SBS-IF clinical trials of teduglutide (NCT01952080 and NCT02682381) were pooled where possible.
    Summary · context
    The primary objective was to evaluate the change in stool consistency, frequency, and volume from baseline to weeks 12 and 24 of treatment in patients who received any teduglutide dose from both studies ("total teduglutide").

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02682381

Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition

Shiren = 5923 Jun 2016 to 18 Aug 2017

Short Bowel Syndrome

CompletedPhase 3Results postedNCT01952080

A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome

Shiren = 4214 Nov 2013 to 9 Jan 2015

Short Bowel Syndrome

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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