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

Last updated: February 25, 2025
Sponsor: Medical University of Warsaw
Overall Status: Terminated

Phase

N/A

Condition

Dysmenorrhea (Painful Periods)

Ulcerative Colitis (Pediatric)

Colic

Treatment

Low-FODMAP diet

Clinical Study ID

NCT04528914
1W44/5FNUT13/20
  • Ages 8-18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • functional abdominal pain - not otherwise specified (FAP-NOS) or irritable bowelsyndrome (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

Exclusion Criteria:

  • receiving any other intervention/treatment with regard to FAP-NOS or IBS or thosewho 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 compliancewith the diet troublesome,

  • previously diagnosed carbohydrate intolerance without symptoms of FAPD afterimplementation 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 theprevious 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 orcommunicate.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Low-FODMAP diet
Phase:
Study Start date:
April 02, 2023
Estimated Completion Date:
December 30, 2024

Study 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).

Connect with a study center

  • Department of Paediatrics, The Medical University of Warsaw

    Warsaw,
    Poland

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.