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NCT04528914

Low-FODMAP Diet for Functional Abdominal Pain Disorders in Children.

Terminated NA Last updated 1 August 2025
What this trial tests

NA trial testing Low-FODMAP diet in Functional Abdominal Pain Disorder in 42 participants. Terminated before completion.

Timeline
2 April 2023
Primary endpoint
30 December 2024
30 December 2024

Quick facts

Lead sponsorMedical University of Warsaw
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment42
Start date2 April 2023
Primary completion30 December 2024
Estimated completion30 December 2024
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Warsaw

Who can join

Adults 8 to 18, any sex, with Functional Abdominal Pain Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This single-center, randomized, controlled, quadruple-blinded, superiority trial is performed to test the hypothesis that children with IBS and FAP-NOS who receive a low-FODMAP diet will have a lower mean abdominal pain intensity score compared with those who receive a regular diet after 4 weeks of intervention.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Gut liver brain axis in diseases: the implications for therapeutic interventions.
    Yan M, Man S, Sun B, Ma L, et al · · 2023 · cited 165× · PMID 38057297 · DOI 10.1038/s41392-023-01673-4
  2. Effect of a low-FODMAP diet for the management of functional abdominal pain disorders in children: a study protocol for a randomized controlled trial.
    Stróżyk A, Horvath A, Muir J, Szajewska H. · · 2021 · cited 4× · PMID 33388067 · DOI 10.1186/s12937-020-00656-3
  3. Efficacy of a low-FODMAP diet in children with irritable bowel syndrome and functional abdominal pain-not otherwise specified: a randomized controlled trial with early termination.
    Stróżyk A, Horvath A, Kozłowska-Jalowska A, Muir J, et al · · 2026 · PMID 41929915 · DOI 10.3389/fped.2026.1809053
  4. Effect of a Low-fodmap Diet for the Management of Functional Abdominal Pain Disorders in Children: A Study Protocol for a Randomized Controlled Trial
    Stróżyk A, Horvath A, Muir J, Szajewska H. · · 2020 · DOI 10.21203/rs.3.rs-73062/v1

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Other trials of Low-FODMAP diet

Trials testing the same drug.

Other Medical University of Warsaw trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04528914.

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