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NCT04528914
Low-FODMAP Diet for Functional Abdominal Pain Disorders in Children.
NA trial testing Low-FODMAP diet in Functional Abdominal Pain Disorder in 42 participants. Terminated before completion.
30 December 2024
Quick facts
| Lead sponsor | Medical University of Warsaw |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 2 April 2023 |
| Primary completion | 30 December 2024 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Low-FODMAP diet
Conditions studied
- Functional Abdominal Pain Disorder — all drugs for Functional Abdominal Pain Disorder →
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):
-
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04528914
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Low-FODMAP diet
Trials testing the same drug.
- NCT05832528 — Low FODMAP Diet in FD (PDS) · NA · recruiting
- NCT05646186 — Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome · NA · unknown
- NCT05159115 — Sucrase-isomaltase Deficiency as a Cause of Irritable Bowel Syndrome · NA · not yet recruiting
- NCT05329571 — The Effects of Dietary Changes on Gut-bacteria and Fibromyalgia Symptoms · NA · unknown
- NCT02471989 — FODMAPs and Refractory GERD · NA · completed
Other Medical University of Warsaw trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04528914 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Warsaw
- Last refreshed: 1 August 2025
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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