Low-FODMAP Diet for Functional Abdominal Pain Disorders in Children.
Reason given: Preliminary results found that there is no difference on abdominal pain intensity between low-FODMAP and regular diet at 4 weeks. Moreover, both diets were difficult to adhere by patients. We do not expect any significant change in our findings.
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Trial details
- Who runs it
- Medical University of Warsaw
- Trial code
- NCT04528914
- Record updated
- 1 August 2025
- Original 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.Read full original descriptionShow less
Effect of a Low-FODMAP Diet for the Management of Functional Abdominal Pain Disorders in Children
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.
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,; chronic illness, receiving medications which affect gastrointestinal motility,; previously diagnosed carbohydrate intolerance without symptoms of FAPD after implementation of an exclusion diet,; unintentional weight loss greater or equal to 5% of subject' body weight within the previous 3 months,; prior surgery of the gastrointestinal tract (within last 3 months),; an organic cause of symptoms or organic gastrointestinal disease,; eating disorders,; need for any other dietary management which could make the balancing or compliance with the diet troublesome,; 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),; pregnancy,; recurrent or unexplained fever,; developmental disabilities which impair the ability of the child to understand or communicate.