Safety and efficacy of linaclotide in children aged 7-17 years with irritable bowel syndrome with constipation.

Di Lorenzo C, Nurko S, Hyams JS, Rodriguez-Araujo G, Shakhnovich V, Saps M, Simon M

Journal of pediatric gastroenterology and nutrition28 Dec 2023Cited by 5 (Europe PMC)

PMID38504394DOI10.1002/jpn3.12103PepBankPUB-38504394

Publisher page PubMedAsk about this study

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.

01HumanRandomized controlled trialEfficacy outcome
In children with IBS-C, linaclotide Dose A showed numerical SBM frequency improvement (reported value 1.62), with improvement compared with placebo.
In plain wordsLinaclotide Dose A numerically improved bowel movement frequency compared with placebo in children with IBS-C.
Peptide
Linaclotide
Outcome
IncreaseOverall SBM frequency, Dose A
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
Dose A: 18 or 36 µg once daily · 4 weeksAs given in this study (human).
Measurements
Reported SBM frequency improvement
1.62 not stated
Dose A
Source sentences
Summary
In the intent-to-treat population, numerical improvement was observed in overall SBM frequency rate with increasing linaclotide doses (A: 1.62, B: 1.52, and C: 2.30, 290 µg: 3.26) compared with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This study evaluated the safety and efficacy of various linaclotide doses in children 7-17 years old with irritable bowel syndrome with constipation (IBS-C).
Report a problemFND-3850439401
02HumanRandomized controlled trialEfficacy outcome
In children with IBS-C, linaclotide Dose B showed numerical SBM frequency improvement (reported value 1.52), with improvement compared with placebo.
In plain wordsLinaclotide Dose B numerically improved bowel movement frequency compared with placebo in children with IBS-C.
Peptide
Linaclotide
Outcome
IncreaseOverall SBM frequency, Dose B
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
Dose B: 36 or 72 µg once daily · 4 weeksAs given in this study (human).
Measurements
Reported SBM frequency improvement
1.52 not stated
Dose B
Source sentences
Summary
In the intent-to-treat population, numerical improvement was observed in overall SBM frequency rate with increasing linaclotide doses (A: 1.62, B: 1.52, and C: 2.30, 290 µg: 3.26) compared with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This study evaluated the safety and efficacy of various linaclotide doses in children 7-17 years old with irritable bowel syndrome with constipation (IBS-C).
Report a problemFND-3850439402
03HumanRandomized controlled trialEfficacy outcome
In children with IBS-C, linaclotide Dose C showed numerical SBM frequency improvement (reported value 2.30), with improvement compared with placebo.
In plain wordsLinaclotide Dose C numerically improved bowel movement frequency compared with placebo in children with IBS-C.
Peptide
Linaclotide
Outcome
IncreaseOverall SBM frequency, Dose C
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
Dose C: 72 or 145 µg once daily · 4 weeksAs given in this study (human).
Measurements
Reported SBM frequency improvement
2.3 not stated
Dose C
Source sentences
Summary
In the intent-to-treat population, numerical improvement was observed in overall SBM frequency rate with increasing linaclotide doses (A: 1.62, B: 1.52, and C: 2.30, 290 µg: 3.26) compared with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This study evaluated the safety and efficacy of various linaclotide doses in children 7-17 years old with irritable bowel syndrome with constipation (IBS-C).
Report a problemFND-3850439403
04HumanRandomized controlled trialEfficacy outcome
In children with IBS-C, linaclotide 290 µg showed numerical SBM frequency improvement (reported value 3.26), with improvement compared with placebo.
In plain wordsLinaclotide 290 µg numerically improved bowel movement frequency compared with placebo in children with IBS-C.
Peptide
Linaclotide
Outcome
IncreaseOverall SBM frequency, 290 µg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
290 µg once daily · 4 weeksAs given in this study (human).
Measurements
Reported SBM frequency improvement
3.26 not stated
290 µg
Source sentences
Summary
In the intent-to-treat population, numerical improvement was observed in overall SBM frequency rate with increasing linaclotide doses (A: 1.62, B: 1.52, and C: 2.30, 290 µg: 3.26) compared with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This study evaluated the safety and efficacy of various linaclotide doses in children 7-17 years old with irritable bowel syndrome with constipation (IBS-C).
Report a problemFND-3850439404

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

TerminatedPhase 2Results postedNCT02559817

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation

Forest Laboratoriesn = 1011 Nov 2015 to 30 Aug 2019

Irritable Bowel Syndrome With Constipation

Trial page ClinicalTrials.govUpdated 28 Dec 2020

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, 16:34 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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