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Study · Randomized controlled trial · n = 57 · 2026

4 results

A post hoc analysis of linaclotide in pediatric patients with functional constipation and neurodevelopmental disorders.

Person H, Hyams JS, Sanghavi RM, Shakhnovich V, Kosch K, Li M, D'Achino D, Khlevner J, Chumpitazi BP, Saps M

Journal of pediatric gastroenterology and nutrition30 Mar 2026Cited by 1 (Europe PMC)

PMID41913506 (opens in a new tab)PMCIDPMC13342784 (opens in a new tab)DOI10.1002/jpn3.70424 (opens in a new tab)PepBankPUB-41913506
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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 study4

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In children with constipation and neurodevelopmental disorders, weekly spontaneous bowel movement frequency increased more with linaclotide than placebo over 12 weeks.

    In plain wordsIn children with constipation and neurodevelopmental disorders, linaclotide increased spontaneous bowel movements more than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseWeekly spontaneous bowel movement frequency
    Study

    n = 57

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    72 µg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Frequency change
    2.09 SBM/week
    linaclotide
    Frequency change
    0.59 SBM/week
    placebo
    Standardized mean difference
    0.688 NA
    linaclotide versus placebo

    Source sentences

    Summary
    CFB in weekly SBM frequency over 12 weeks was greater with linaclotide versus placebo (2.09 vs. 0.59, respectively; SMD 0.688).
    2 context sentences
    Summary · context
    This post hoc analysis of a Phase 3, randomized, placebo-controlled study assessed oral linaclotide 72 µg once daily for 12 weeks in patients aged 6-17 years with FC and NDD.
    Summary · context
    In this analysis of 57 pediatric patients (linaclotide n = 25; placebo n = 32), 91% had attention-deficit/hyperactivity disorder; other NDDs included autism spectrum disorder, tic disorders, and sensory processing disorders.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In children with constipation and neurodevelopmental disorders, stool consistency improved more with linaclotide than placebo, with changes of 1.37 versus 0.55.

    In plain wordsIn children with constipation and neurodevelopmental disorders, linaclotide improved stool consistency more than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseStool consistency
    Study

    n = 57

    Comparator
    Placebo
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    72 µg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Consistency change
    1.37 score
    linaclotide
    Consistency change
    0.55 score
    placebo

    Source sentences

    Summary
    Linaclotide was also associated with greater improvements relative to placebo in stool consistency (CFB 1.37 vs. 0.55, respectively) and straining score (CFB -0.98 vs. -0.59).
    2 context sentences
    Summary · context
    This post hoc analysis of a Phase 3, randomized, placebo-controlled study assessed oral linaclotide 72 µg once daily for 12 weeks in patients aged 6-17 years with FC and NDD.
    Summary · context
    In this analysis of 57 pediatric patients (linaclotide n = 25; placebo n = 32), 91% had attention-deficit/hyperactivity disorder; other NDDs included autism spectrum disorder, tic disorders, and sensory processing disorders.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In children with constipation and neurodevelopmental disorders, straining scores decreased more with linaclotide than placebo, at -0.98 versus -0.59.

    In plain wordsIn children with constipation and neurodevelopmental disorders, linaclotide reduced straining more than placebo.

    Peptide
    Linaclotide
    Outcome
    DecreaseStraining score
    Study

    n = 57

    Comparator
    Placebo
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    72 µg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Straining change
    −0.98 score
    linaclotide
    Straining change
    −0.59 score
    placebo

    Source sentences

    Summary
    Linaclotide was also associated with greater improvements relative to placebo in stool consistency (CFB 1.37 vs. 0.55, respectively) and straining score (CFB -0.98 vs. -0.59).
    2 context sentences
    Summary · context
    This post hoc analysis of a Phase 3, randomized, placebo-controlled study assessed oral linaclotide 72 µg once daily for 12 weeks in patients aged 6-17 years with FC and NDD.
    Summary · context
    In this analysis of 57 pediatric patients (linaclotide n = 25; placebo n = 32), 91% had attention-deficit/hyperactivity disorder; other NDDs included autism spectrum disorder, tic disorders, and sensory processing disorders.
  4. 04HumanNon-randomized trialSafety outcome

    In children with constipation and neurodevelopmental disorders, linaclotide was well tolerated, with a safety profile consistent with previous reports.

    In plain wordsIn children with constipation and neurodevelopmental disorders, linaclotide was well tolerated, consistent with previous safety reports.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedTolerability
    Study

    n = 25

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    72 µg once daily · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Linaclotide was well tolerated, with a safety profile consistent with that reported previously.
    2 context sentences
    Summary · context
    This post hoc analysis of a Phase 3, randomized, placebo-controlled study assessed oral linaclotide 72 µg once daily for 12 weeks in patients aged 6-17 years with FC and NDD.
    Summary · context
    In this analysis of 57 pediatric patients (linaclotide n = 25; placebo n = 32), 91% had attention-deficit/hyperactivity disorder; other NDDs included autism spectrum disorder, tic disorders, and sensory processing disorders.

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 3Results postedNCT04026113

Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

AbbVien = 4381 Oct 2019 to 29 May 2024

Functional Constipation · Irritable Bowel Syndrome With Constipation

Trial pageClinicalTrials.govUpdated 26 Nov 2024

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, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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