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Study · Randomized controlled trial · n = 6 · 2022

4 results

Teduglutide for the treatment of low-output enterocutaneous fistula - A pilot randomized controlled study.

Yeh DD, Vasileiou G, Abdul Jawad K, Pust GD, Byers PM

Clinical nutrition ESPEN12 May 2022Cited by 4 (Europe PMC)

PMID35871951 (opens in a new tab)DOI10.1016/j.clnesp.2022.04.031 (opens in a new tab)PepBankPUB-35871951
Publisher pagePubMedAsk about this study
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    Five of six adults met the fistula-volume response endpoint during teduglutide treatment, but not during their standard-care arm.

    In plain wordsFive of six adults had the defined fistula-volume response with teduglutide, but not with standard care.

    Peptide
    Teduglutide
    Outcome
    DecreaseFistula volume response
    Study

    n = 6

    Comparator
    Standard care
    Analysis
    Primary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated · 2 monthsAs given in this study (human).

    Measurements

    Subjects meeting primary endpoint (fistula volume decrease)
    5 subjects
    during teduglutide treatment; five of six enrolled subjects

    Source sentences

    Summary
    Five of six enrolled subjects met the definition for the primary efficacy endpoint; these clinical responses were not observed during the SOC arm in these subjects.
    3 context sentences
    Summary · context
    The primary efficacy endpoint was decrease in fistula volume by 20% of baseline 3-day average.
    Summary · context
    Adults (age >18) with low-output (<200 mL/d) ECF were randomized to 2 months of continuing standard-of-care (SOC) followed by crossover to 2 months of SOC + TED or the reverse order.
    Summary · context
    Six out of 10 planned subjects were randomized and completed the study, which was terminated early due to slow enrollment during the Covid-19 pandemic.
  2. 02HumanNon-randomized trialEfficacy outcome

    One adult experienced complete fistula closure during teduglutide treatment.

    In plain wordsOne adult had complete intestinal fistula closure during teduglutide treatment.

    Peptide
    Teduglutide
    Outcome
    Not applicableComplete fistula closure
    Study

    n = 6

    Analysis
    Secondary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated · 2 monthsAs given in this study (human).

    Measurements

    Subjects with complete fistula closure
    1 subjects
    during TED treatment

    Source sentences

    Summary
    One subject experienced complete fistula closure during TED treatment.
    2 context sentences
    Summary · context
    Adults (age >18) with low-output (<200 mL/d) ECF were randomized to 2 months of continuing standard-of-care (SOC) followed by crossover to 2 months of SOC + TED or the reverse order.
    Summary · context
    Six out of 10 planned subjects were randomized and completed the study, which was terminated early due to slow enrollment during the Covid-19 pandemic.
  3. 03HumanNon-randomized trialOther

    In adults with low-output ECF, compliance with daily teduglutide injections was 98%.

    In plain wordsAdults with low-output intestinal fistulas completed 98% of daily teduglutide injections.

    Peptide
    Teduglutide
    Outcome
    Not applicableInjection compliance
    Study

    n = 6

    Outcome group
    Treatment adherence and retention · Gastrointestinal
    Studied dose
    Dose not stated · 2 monthsAs given in this study (human).

    Measurements

    Compliance with daily TED injections
    98%
    overall subject compliance

    Source sentences

    Summary
    Overall subject compliance with daily TED injections was high (98%).
    2 context sentences
    Summary · context
    Adults (age >18) with low-output (<200 mL/d) ECF were randomized to 2 months of continuing standard-of-care (SOC) followed by crossover to 2 months of SOC + TED or the reverse order.
    Summary · context
    Six out of 10 planned subjects were randomized and completed the study, which was terminated early due to slow enrollment during the Covid-19 pandemic.
  4. 04HumanNon-randomized trialSafety outcome

    In adults with ECF, adverse events during teduglutide treatment were uncommon, minor, and usually resolved despite continued treatment.

    In plain wordsIn adults with intestinal fistulas, adverse events during teduglutide treatment were uncommon, minor, and usually resolved during treatment.

    Peptide
    Teduglutide
    Outcome
    Not applicableAdverse events
    Study

    n = 6

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 2 monthsAs given in this study (human).

    Source sentences

    Summary
    Adverse events during treatment were uncommon, minor, and usually resolved despite ongoing treatment.
    2 context sentences
    Summary · context
    Adults (age >18) with low-output (<200 mL/d) ECF were randomized to 2 months of continuing standard-of-care (SOC) followed by crossover to 2 months of SOC + TED or the reverse order.
    Summary · context
    Six out of 10 planned subjects were randomized and completed the study, which was terminated early due to slow enrollment during the Covid-19 pandemic.

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

Registered trials1

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

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT02889393

Teduglutide for Enterocutaneous Fistula (ECF)

Daniel Dante Yehn = 631 Jan 2019 to 15 Jul 2021

Postoperative Fistula

Trial pageClinicalTrials.govUpdated 6 Oct 2021

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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