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

NCT04528914 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-08-01

No results posted yet for this study

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.

Conditions

  • Functional Abdominal Pain Disorder

Interventions

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).

Sponsors & Collaborators

  • Nutricia Foundation

    collaborator OTHER

  • Medical University of Warsaw

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-02
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04528914 on ClinicalTrials.gov