Status:
TERMINATED
Low-FODMAP Diet for Functional Abdominal Pain Disorders in Children.
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
Nutricia Foundation
Conditions:
Functional Abdominal Pain Disorder
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief 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 ...
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 functio...
Eligibility Criteria
Inclusion
- functional abdominal pain - not otherwise specified (FAP-NOS) or irritable bowel syndrome (IBS) diagnosed according to the Rome IV Criteria,
- baseline average pain intensity at least 30 mm on a 100-mm Visual Analogue Scale,
- feeding via the oral route,
- ability to read and comprehend any employed questionnaires/scales,
- signed informed consent,
- stated availability throughout the study period.
Exclusion
- receiving any other intervention/treatment with regard to FAP-NOS or IBS or those who received any other intervention during the last 3 months,
- an organic cause of symptoms or organic gastrointestinal disease,
- chronic illness, receiving medications which affect gastrointestinal motility,
- need for any other dietary management which could make the balancing or compliance with the diet troublesome,
- previously diagnosed carbohydrate intolerance without symptoms of FAPD after implementation of an exclusion diet,
- undernutrition (defined as World Health Organization \[WHO\] growth charts \< -2 SD), decreased growth velocity (sharp decline in growth line), or overweight or obese (\> 1 or \> 2 SD on the WHO growth charts, respectively),
- unintentional weight loss greater or equal to 5% of subject' body weight within the previous 3 months,
- pregnancy,
- eating disorders,
- prior surgery of the gastrointestinal tract (within last 3 months),
- recurrent or unexplained fever,
- developmental disabilities which impair the ability of the child to understand or communicate.
Key Trial Info
Start Date :
April 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04528914
Start Date
April 2 2023
End Date
December 30 2024
Last Update
August 1 2025
Active Locations (1)
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1
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Poland