Study · Randomized controlled trial · n = 83 · 2011

8 results

Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome.

Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ

Gut11 Feb 2011Cited by 323 (Europe PMC)

PMID21317170PMCIDPMC3112364DOI10.1136/gut.2010.218271PepBankPUB-21317170

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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. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with short bowel syndrome, teduglutide 0.05 mg/kg/day significantly improved GRS versus placebo (16/35, p = 0.007).
In plain wordsIn patients with short bowel syndrome, teduglutide 0.05 mg/kg/day improved graded response versus placebo.
Peptide
Teduglutide
Outcome
IncreaseGraded response score
Study
n = 51
Comparator
placebo
Analysis
Primary
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
GRS responders
16 patients
teduglutide 0.05 mg/kg/day (n = 35)
GRS responders
1 patients
placebo (n = 16)
p value
0.007
versus placebo
Source sentences
Summary
Using the GRS criteria, teduglutide in a dose of 0.10 mg/kg/day did not have a statistically significant effect compared with placebo (8/32 vs 1/16, p=0.16), while teduglutide in a dose of 0.05 mg/kg/day had a significant effect (16/35, p = 0.007).
2 context sentences(design, population, supporting numbers)
Summary · context
This 24-week placebo-controlled study evaluated the ability of teduglutide to reduce parenteral support in patients with SBS with intestinal failure.
Summary · context
In 83 patients randomised to receive subcutaneous teduglutide 0.10 mg/kg/day (n = 32), 0.05 mg/kg/day (n = 35) or placebo (n = 16) once daily, parenteral fluids were reduced at 4-week intervals if intestinal fluid absorption (48 h urine volumes) increased ≥ 10%.
Report a problemFND-2131717002
02HumanRandomized controlled trialEfficacy outcome
In patients with short bowel syndrome, teduglutide 0.10 mg/kg/day had no significant GRS effect versus placebo (8/32 versus 1/16, p=0.16).
In plain wordsIn patients with short bowel syndrome, teduglutide 0.10 mg/kg/day showed no significant graded response benefit versus placebo.
Peptide
Teduglutide
Outcome
No significant changeGraded response score
Study
n = 48
Comparator
placebo
Analysis
Primary
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.10 mg/kg/day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
GRS responders
8 patients
teduglutide 0.10 mg/kg/day (n = 32)
GRS responders
1 patients
placebo (n = 16)
p value
0.16
versus placebo
Source sentences
Summary
Using the GRS criteria, teduglutide in a dose of 0.10 mg/kg/day did not have a statistically significant effect compared with placebo (8/32 vs 1/16, p=0.16), while teduglutide in a dose of 0.05 mg/kg/day had a significant effect (16/35, p = 0.007).
2 context sentences(design, population, supporting numbers)
Summary · context
This 24-week placebo-controlled study evaluated the ability of teduglutide to reduce parenteral support in patients with SBS with intestinal failure.
Summary · context
In 83 patients randomised to receive subcutaneous teduglutide 0.10 mg/kg/day (n = 32), 0.05 mg/kg/day (n = 35) or placebo (n = 16) once daily, parenteral fluids were reduced at 4-week intervals if intestinal fluid absorption (48 h urine volumes) increased ≥ 10%.
Report a problemFND-2131717001
03HumanRandomized controlled trialSafety outcome
In patients with short bowel syndrome, serious adverse events were distributed similarly between teduglutide groups and placebo.
In plain wordsIn patients with short bowel syndrome, serious adverse events were similar with teduglutide and placebo.
Peptide
Teduglutide
Outcome
Direction not reportedSerious adverse events
Study
n = 83
Comparator
placebo
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Serious adverse events were distributed similarly between active treatment groups and placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
This 24-week placebo-controlled study evaluated the ability of teduglutide to reduce parenteral support in patients with SBS with intestinal failure.
Summary · context
In 83 patients randomised to receive subcutaneous teduglutide 0.10 mg/kg/day (n = 32), 0.05 mg/kg/day (n = 35) or placebo (n = 16) once daily, parenteral fluids were reduced at 4-week intervals if intestinal fluid absorption (48 h urine volumes) increased ≥ 10%.
Report a problemFND-2131717005
04HumanRandomized controlled trialEfficacy outcome
In patients with short bowel syndrome, parenteral volume reductions were equal with teduglutide doses (353 ± 475 versus 354 ± 334 ml/day).
In plain wordsIn patients with short bowel syndrome, parenteral volume reductions were equal with teduglutide 0.10 and 0.05 mg/kg/day.
Peptide
Teduglutide
Outcome
Direction not reportedParenteral volume reduction
Study
n = 67
Comparator
teduglutide 0.05 mg/kg/day
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.10 and 0.05 mg/kg/day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Volume reduction
353 ml/day
0.10 mg/kg/day; ± 475
Volume reduction
354 ml/day
0.05 mg/kg/day; ± 334
Source sentences
Summary
Since parenteral volume reductions were equal (353 ± 475 and 354 ± 334 ml/day), the trend towards higher baseline parenteral volume (1816 ± 1008 vs 1374 ± 639 ml/day, p=0.11) in the 0.10 mg/kg/day group compared with the 0.05 mg/kg/day group may have accounted for this discrepancy.
2 context sentences(design, population, supporting numbers)
Summary · context
This 24-week placebo-controlled study evaluated the ability of teduglutide to reduce parenteral support in patients with SBS with intestinal failure.
Summary · context
In 83 patients randomised to receive subcutaneous teduglutide 0.10 mg/kg/day (n = 32), 0.05 mg/kg/day (n = 35) or placebo (n = 16) once daily, parenteral fluids were reduced at 4-week intervals if intestinal fluid absorption (48 h urine volumes) increased ≥ 10%.
Report a problemFND-2131717003
05HumanRandomized controlled trialEfficacy outcome
In patients with short bowel syndrome, teduglutide significantly increased villus height versus placebo.
In plain wordsIn patients with short bowel syndrome, teduglutide increased intestinal villus height versus placebo.
Peptide
Teduglutide
Outcome
IncreaseVillus height
Study
n: not reported in source
Comparator
placebo
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
Dose not stated · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Villus height, plasma citrulline concentration and lean body mass were significantly increased with teduglutide compared with placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
This 24-week placebo-controlled study evaluated the ability of teduglutide to reduce parenteral support in patients with SBS with intestinal failure.
Summary · context
In 83 patients randomised to receive subcutaneous teduglutide 0.10 mg/kg/day (n = 32), 0.05 mg/kg/day (n = 35) or placebo (n = 16) once daily, parenteral fluids were reduced at 4-week intervals if intestinal fluid absorption (48 h urine volumes) increased ≥ 10%.
Report a problemFND-2131717006
06HumanRandomized controlled trialEfficacy outcome
In patients with short bowel syndrome, teduglutide significantly increased plasma citrulline concentration versus placebo.
In plain wordsIn patients with short bowel syndrome, teduglutide increased plasma citrulline versus placebo.
Peptide
Teduglutide
Outcome
IncreasePlasma citrulline
Study
n: not reported in source
Comparator
placebo
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
Dose not stated · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Villus height, plasma citrulline concentration and lean body mass were significantly increased with teduglutide compared with placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
This 24-week placebo-controlled study evaluated the ability of teduglutide to reduce parenteral support in patients with SBS with intestinal failure.
Summary · context
In 83 patients randomised to receive subcutaneous teduglutide 0.10 mg/kg/day (n = 32), 0.05 mg/kg/day (n = 35) or placebo (n = 16) once daily, parenteral fluids were reduced at 4-week intervals if intestinal fluid absorption (48 h urine volumes) increased ≥ 10%.
Report a problemFND-2131717007
07HumanRandomized controlled trialEfficacy outcome
In patients with short bowel syndrome, teduglutide significantly increased lean body mass versus placebo.
In plain wordsIn patients with short bowel syndrome, teduglutide increased lean body mass versus placebo.
Peptide
Teduglutide
Outcome
IncreaseLean body mass
Study
n: not reported in source
Comparator
placebo
Outcome group
Body composition · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Villus height, plasma citrulline concentration and lean body mass were significantly increased with teduglutide compared with placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
This 24-week placebo-controlled study evaluated the ability of teduglutide to reduce parenteral support in patients with SBS with intestinal failure.
Summary · context
In 83 patients randomised to receive subcutaneous teduglutide 0.10 mg/kg/day (n = 32), 0.05 mg/kg/day (n = 35) or placebo (n = 16) once daily, parenteral fluids were reduced at 4-week intervals if intestinal fluid absorption (48 h urine volumes) increased ≥ 10%.
Report a problemFND-2131717008
08HumanNon-randomized trialEfficacy outcome
In patients with short bowel syndrome, three teduglutide-treated patients completely discontinued parenteral support.
In plain wordsIn patients with short bowel syndrome, three patients receiving teduglutide no longer needed parenteral support.
Peptide
Teduglutide
Outcome
Not applicableComplete weaning from parenteral support
Study
n = 67
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
Dose not stated · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Patients completely weaned off parenteral support
3 patients
teduglutide-treated
Source sentences
Summary
Three teduglutide-treated patients were completely weaned off parenteral support.
2 context sentences(design, population, supporting numbers)
Summary · context
This 24-week placebo-controlled study evaluated the ability of teduglutide to reduce parenteral support in patients with SBS with intestinal failure.
Summary · context
In 83 patients randomised to receive subcutaneous teduglutide 0.10 mg/kg/day (n = 32), 0.05 mg/kg/day (n = 35) or placebo (n = 16) once daily, parenteral fluids were reduced at 4-week intervals if intestinal fluid absorption (48 h urine volumes) increased ≥ 10%.
Report a problemFND-2131717004

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

Registered trials3

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

3 trials · 3 completed · 3 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 page ClinicalTrials.govUpdated 6 Oct 2021

CompletedPhase 3Results postedNCT00172185

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

Shiren = 6510 Jan 2005 to 24 Jan 2008

Short Bowel Syndrome

Trial page ClinicalTrials.govUpdated 2 Jun 2021

CompletedPhase 3Results postedNCT00081458

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

Shiren = 8425 May 2004 to 6 Jul 2007

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

Subjects

Terms as the source lists them.

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