Study · Non-randomized trial · 2017

13 results

Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome.

Carter BA, Cohran VC, Cole CR, Corkins MR, Dimmitt RA, Duggan C, Hill S, Horslen S, Lim JD, Mercer DF, Merritt RJ, Nichol PF and 9 more

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Sigurdsson L, Teitelbaum DH, Thompson J, Vanderpool C, Vaughan JF, Li B, Youssef NN, Venick RS, Kocoshis SA

The Journal of pediatrics15 Nov 2016Cited by 135 (Europe PMC)

PMID27855998DOI10.1016/j.jpeds.2016.10.027PepBankPUB-27855998

Publisher page PubMedAsk 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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

01HumanNon-randomized trialSafety outcome
In children with SBS-IF, all patients, including teduglutide recipients, experienced at least one treatment-emergent adverse event, mostly mild or moderate.
In plain wordsIn children with SBS-IF, all patients, including teduglutide recipients, had adverse events during treatment. Most events were mild or moderate.
Peptide
Teduglutide
Outcome
Not applicableTreatment-emergent adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · 12 weeksAs given in this study (human).
Source sentences
Summary
All patients experienced ≥1 treatment-emergent adverse event; most were mild or moderate.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599801
02HumanNon-randomized trialSafety outcome
In children with SBS-IF, no serious teduglutide-related treatment-emergent adverse events occurred.
In plain wordsIn children with SBS-IF, no serious adverse events related to teduglutide occurred.
Peptide
Teduglutide
Outcome
Not applicableSerious teduglutide-related adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · 12 weeksAs given in this study (human).
Source sentences
Summary
No serious teduglutide-related treatment-emergent adverse events occurred.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599802
03HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, prescribed PN volume changed by a median of -41% from baseline to week 12 with teduglutide 0.025 mg/kg/d.
In plain wordsIn children with SBS-IF, intravenous nutrition volume fell from baseline with teduglutide 0.025 mg/kg/d.
Peptide
Teduglutide
Outcome
DecreasePrescribed PN volume change
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.025 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Median change in prescribed PN volume
−41%
0.025 mg/kg/d cohort, baseline to week 12
Source sentences
Summary
Between baseline and week 12, prescribed PN volume and calories (kcal/kg/d) changed by a median of -41% and -45%, respectively, with 0.025 mg/kg/d teduglutide and by -25% and -52% with 0.05 mg/kg/d teduglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599803
04HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, prescribed PN calories changed by a median of -45% from baseline to week 12 with teduglutide 0.025 mg/kg/d.
In plain wordsIn children with SBS-IF, intravenous nutrition calories fell from baseline with teduglutide 0.025 mg/kg/d.
Peptide
Teduglutide
Outcome
DecreasePrescribed PN calorie change
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.025 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Median change in prescribed PN calories
−45%
0.025 mg/kg/d cohort, baseline to week 12
Source sentences
Summary
Between baseline and week 12, prescribed PN volume and calories (kcal/kg/d) changed by a median of -41% and -45%, respectively, with 0.025 mg/kg/d teduglutide and by -25% and -52% with 0.05 mg/kg/d teduglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599804
05HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, prescribed PN volume changed by a median of -25% from baseline to week 12 with teduglutide 0.05 mg/kg/d.
In plain wordsIn children with SBS-IF, intravenous nutrition volume fell from baseline with teduglutide 0.05 mg/kg/d.
Peptide
Teduglutide
Outcome
DecreasePrescribed PN volume change
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Median change in prescribed PN volume
−25%
0.05 mg/kg/d cohort, baseline to week 12
Source sentences
Summary
Between baseline and week 12, prescribed PN volume and calories (kcal/kg/d) changed by a median of -41% and -45%, respectively, with 0.025 mg/kg/d teduglutide and by -25% and -52% with 0.05 mg/kg/d teduglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599805
06HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, prescribed PN calories changed by a median of -52% from baseline to week 12 with teduglutide 0.05 mg/kg/d.
In plain wordsIn children with SBS-IF, intravenous nutrition calories fell from baseline with teduglutide 0.05 mg/kg/d.
Peptide
Teduglutide
Outcome
DecreasePrescribed PN calorie change
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Median change in prescribed PN calories
−52%
0.05 mg/kg/d cohort, baseline to week 12
Source sentences
Summary
Between baseline and week 12, prescribed PN volume and calories (kcal/kg/d) changed by a median of -41% and -45%, respectively, with 0.025 mg/kg/d teduglutide and by -25% and -52% with 0.05 mg/kg/d teduglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599806
07HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, prescribed PN volume changed by a median of 0% with teduglutide 0.0125 mg/kg/d.
In plain wordsIn children with SBS-IF, median intravenous nutrition volume did not change from baseline with teduglutide 0.0125 mg/kg/d.
Peptide
Teduglutide
Outcome
No significant changePrescribed PN volume change
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.0125 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Median change in prescribed PN volume
0%
0.0125 mg/kg/d cohort, baseline to week 12
Source sentences
Summary
In contrast, PN volume and calories changed by 0% and -6%, respectively, with 0.0125 mg/kg/d teduglutide and by 0% and -1% with SOC.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599807
08HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, prescribed PN calories changed by a median of -6% with teduglutide 0.0125 mg/kg/d.
In plain wordsIn children with SBS-IF, intravenous nutrition calories fell from baseline with teduglutide 0.0125 mg/kg/d.
Peptide
Teduglutide
Outcome
DecreasePrescribed PN calorie change
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.0125 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Median change in prescribed PN calories
−6%
0.0125 mg/kg/d cohort, baseline to week 12
Source sentences
Summary
In contrast, PN volume and calories changed by 0% and -6%, respectively, with 0.0125 mg/kg/d teduglutide and by 0% and -1% with SOC.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599808
09HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, diary-recorded EN volume increased by a median of 22% with teduglutide 0.0125 mg/kg/d and by 11% with standard of care.
In plain wordsIn children with SBS-IF, enteral nutrition volume rose from baseline with teduglutide 0.0125 mg/kg/d and also rose with standard of care.
Peptide
Teduglutide
Outcome
IncreaseEN volume change
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.0125 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Median change in EN volume (patient diary)
22%
0.0125 mg/kg/d cohort
Median change in EN volume (patient diary)
11%
standard of care cohort
Source sentences
Summary
Per patient diary data, EN volume increased by a median of 22%, 32%, and 40% in the 0.0125, 0.025, and 0.05 mg/kg/d cohorts, respectively, and by 11% with SOC.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599809
10HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, diary-recorded EN volume increased by a median of 32% with teduglutide 0.025 mg/kg/d and by 11% with standard of care.
In plain wordsIn children with SBS-IF, enteral nutrition volume rose from baseline with teduglutide 0.025 mg/kg/d and also rose with standard of care.
Peptide
Teduglutide
Outcome
IncreaseEN volume change
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.025 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Median change in EN volume (patient diary)
32%
0.025 mg/kg/d cohort
Median change in EN volume (patient diary)
11%
standard of care cohort
Source sentences
Summary
Per patient diary data, EN volume increased by a median of 22%, 32%, and 40% in the 0.0125, 0.025, and 0.05 mg/kg/d cohorts, respectively, and by 11% with SOC.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599810
11HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, diary-recorded EN volume increased by a median of 40% with teduglutide 0.05 mg/kg/d and by 11% with standard of care.
In plain wordsIn children with SBS-IF, enteral nutrition volume rose from baseline with teduglutide 0.05 mg/kg/d and also rose with standard of care.
Peptide
Teduglutide
Outcome
IncreaseEN volume change
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Median change in EN volume (patient diary)
40%
0.05 mg/kg/d cohort
Median change in EN volume (patient diary)
11%
standard of care cohort
Source sentences
Summary
Per patient diary data, EN volume increased by a median of 22%, 32%, and 40% in the 0.0125, 0.025, and 0.05 mg/kg/d cohorts, respectively, and by 11% with SOC.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599811
12HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, 3 patients achieved PN independence in the teduglutide 0.05 mg/kg/d cohort.
In plain wordsThree children with SBS-IF became independent of intravenous nutrition with teduglutide 0.05 mg/kg/d.
Peptide
Teduglutide
Outcome
Not applicablePN independence
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Patients achieving PN independence
3 patients
0.05 mg/kg/d cohort
Source sentences
Summary
Four patients achieved independence from PN, 3 in the 0.05 mg/kg/d cohort and 1 in the 0.025 mg/kg/d cohort.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599812
13HumanNon-randomized trialEfficacy outcome
In children with SBS-IF, 1 patient achieved PN independence in the teduglutide 0.025 mg/kg/d cohort.
In plain wordsOne child with SBS-IF became independent of intravenous nutrition with teduglutide 0.025 mg/kg/d.
Peptide
Teduglutide
Outcome
Not applicablePN independence
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.025 mg/kg/d · 12 weeksAs given in this study (human).
Measurements
Patients achieving PN independence
1 patient
0.025 mg/kg/d cohort
Source sentences
Summary
Four patients achieved independence from PN, 3 in the 0.05 mg/kg/d cohort and 1 in the 0.025 mg/kg/d cohort.
2 context sentences(design, population, supporting numbers)
Summary · context
This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds.
Summary · context
Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5).
Report a problemFND-2785599813

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

CompletedPhase not statedNCT04832087

Pediatric Teduglutide Registry

Boston Children's Hospitaln = 14218 May 2021 to 31 Aug 2023

Short Bowel Syndrome

Trial page ClinicalTrials.govUpdated 11 Dec 2023

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

Trial page ClinicalTrials.govUpdated 9 Jun 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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome.

Summary

Results from this study13

Registered trials2

Pediatric Teduglutide Registry

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

Version history

Subjects

Publication types

MeSH terms

Keywords