Evidence map›Paper›PMID 41913506›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2026

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

Hannibal Person, Jeffrey S Hyams, Rinarani M Sanghavi, Valentina Shakhnovich, Katherine Kosch, Moming Li, Danielle D'Achino, Julie Khlevner, Bruno P Chumpitazi, Miguel Saps

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04026113 (A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide in Pediatric Participants, Ages 6 to 17 Years, With Irritable Bowel Syndrome With Constipation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04026113 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide in Pediatric Participants, Ages 6 to 17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) and of Linaclotide Versus Placebo in Pediatric Participants With Functional Constipation (FC)

TypeinterventionalSponsorAbbVieRan2019 to 2024Enrolled438ConditionsFunctional Constipation, Irritable Bowel Syndrome With ConstipationArmsLinaclotide, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Hannibal PersonDepartment of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.ORCID https://orcid.org/0000-0002-1509-8296
Jeffrey S HyamsDepartment of Gastroenterology, Connecticut Children's Medical Center, Hartford, Connecticut, USA.
Rinarani M SanghaviDepartment of Pediatrics, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Valentina ShakhnovichIronwood Pharmaceuticals, Inc., Boston, Massachusetts, USA.
Katherine KoschAbbVie Inc., North Chicago, Illinois, USA.
Moming LiAbbVie Inc., North Chicago, Illinois, USA.
Danielle D'AchinoIronwood Pharmaceuticals, Inc., Boston, Massachusetts, USA.
Julie KhlevnerDepartment of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA.
Bruno P ChumpitaziDepartment of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
Miguel SapsMiller School of Medicine, University of Miami, Miami, Florida, USA.

Funding

AbbVie, IncIronwood Pharmaceuticals, IncOxford PharmaGenesis, Oxford, UK
6 · The paper itself

Abstract

objectivesFunctional constipation (FC) is common in children with comorbid neurodevelopmental disorders (NDD) and its optimal treatment may be challenged by adherence and medication tolerability issues in this population. We assessed the efficacy and safety of linaclotide in pediatric patients with FC and NDD.

methodsThis 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. The primary endpoint was change from baseline (CFB) in weekly spontaneous bowel movement (SBM) frequency. In efficacy comparisons, an absolute standardized mean difference (SMD) > 0.2 was considered indicative of a treatment difference.

resultsIn 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. CFB in weekly SBM frequency over 12 weeks was greater with linaclotide versus placebo (2.09 vs. 0.59, respectively; SMD 0.688). 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). Most patients (≥96%) achieved ≥80% dosing compliance with once-daily administration of linaclotide or placebo. Linaclotide was well tolerated, with a safety profile consistent with that reported previously.

conclusionsIn children with FC and comorbid NDD, linaclotide 72 µg once daily was associated with improved constipation outcomes, high adherence, and a well-tolerated safety profile, similar to that seen in the overall study population.

trial registrationClinicalTrials.gov identifier: NCT04026113 (https://clinicaltrials.gov/study/NCT04026113).

Indexed as

ConstipationNeurodevelopmental DisordersPeptidesAdolescentChildDouble-Blind MethodFemaleHumansMaleTreatment OutcomelinaclotidePeptidesattention deficit hyperactivity disorderautism spectrum disorderdisorder of gut‐brain interaction

Identifiers

PMID41913506
PMCPMC13342784

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.