NCT04528914

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

Effect of a Low-FODMAP Diet for the Management of Functional Abdominal Pain Disorders in Children

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Introduction. Evidence from studies in adults documents that fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may be triggers of symptoms in individuals with functional abdominal pain disorders. However, in children with FAPDs, there is a need for high-quality evidence regarding the dietary management. We aim to assess the effects of a low-FODMAP diet compared with a regular diet for the management of children with FAPDs. Methods. In this trial, seventy-four children aged 8 to 18 years with a Functional Abdominal Pain Disorder (Irritable Bowel Syndrome or Functional Abdominal Pain-Not Otherwise Specified), diagnosed according to the Rome IV criteria, will be randomly allocated to receive either a low-FODMAP diet or a regular diet for 4 weeks.A primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a Visual Analogue Scale (VAS) during the last week of the trial compared with baseline, that is at least equal to the Reliable Change Index (≥ 25 mm change on VAS).

Conditions

• Functional Abdominal Pain Disorder

Interventions

Type	Name	Description
OTHER	Low-FODMAP diet	The low-FODMAP diet will contain the amount of FODMAPs that will not exceed the cut-offs for each FODMAP sugar per serving of food per sitting. Diets will be individually tailored by dietitian and delivered by a catering company (five meals each day).

Timeline

• Start date: 2023-04-02
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2020-08-27
• Last updated: 2025-08-01

Locations

1 site across 1 country: Poland