Efficacy of a Low-FODMAP Diet for Pediatric IBS and FAP-NOS: A Randomized Controlled Trial

A 25.0 KB document by Agata Stróżyk details an early-terminated randomized controlled trial comparing a low-FODMAP diet to a regular diet in children with irritable bowel syndrome or functional abdominal pain. The trial, registered as NCT04528914, randomized 42 children and collected primary outcome data from 26 participants. Results from this 4-week intervention, last updated in March 2026, show no significant difference in the primary responder rate but a greater mean reduction in pain intensity in the low-FODMAP group.

Use Cases

• Analyzing trial design and recruitment challenges in pediatric dietary studies based on the early termination and participant numbers described.
• Comparing intervention efficacy for abdominal pain reduction based on the reported visual analog scale scores and responder rates.
• Studying adverse event profiles in controlled dietary interventions based on the reported count of rare adverse events.
• Informing future trial methodology based on the described practical challenges related to school settings and caregiver involvement.

Strengths

• Data is from a registered clinical trial (NCT04528914), providing a structured research context.
• The description includes specific statistical results, such as a mean pain reduction difference of -20.8 mm with a 95% confidence interval.
• The document is licensed under CC-BY-4.0, permitting open sharing and adaptation.

Limitations

• The dataset is a 25.0 KB DOCX file, indicating a very limited scope, likely containing only a summary table or manuscript.
• Row count and column-level documentation are absent; field semantics must be inferred from the textual description.
• The trial was terminated early after randomizing 57% of the planned sample, limiting statistical power.

Provenance

Source

Agata Stróżyk via figshare.

Collection Method

Data was collected as part of a randomized controlled trial.

Time Range

The 4-week intervention period is specified, but the overall study dates are not provided.

Freshness

Last updated 2026-03-18 07:15:15.