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

Medical University of Warsaw42 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Functional Abdominal Pain Disorder

Interventions

Low-FODMAP dietOTHER

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).

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

Department of Paediatrics, The Medical University of Warsaw

Warsaw, Poland

Outcomes

Primary Outcomes

Change in abdominal pain intensity

The 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 100-mm 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).

Time frame: At week 1, 2, 3 and 4 from baseline.

Secondary Outcomes

Change in stool consistency

Bristol Stool Scale is a seven-point scale that distinguish seven pictures of different forms of stool, ranging from the hardest (type 1) to the softest (type 7). At baseline, participants with IBS and a stool consistency score \> 5 on the Bristol Stool Scale will be classified as having IBS with predominant diarrhea (IBS-D); if the stool consistency score is \< 3, the subjects will be classified as having IBS with predominant constipation (IBS-C). Responders will be subjects with improvement in their average stool consistency during the last week of the trial compared with baseline \[≥1 higher Bristol Stool Scale score in case of IBS with predominant constipation, or at least one lower score in case of IBS with predominant diarrhea\].

Time frame: At week 1, 2, 3 and 4 from baseline.

Change in abdominal pain frequency

Time frame: At week 1, 2, 3 and 4 from baseline.

Change in Gastrointestinal Symptom Rating Scale (GSRS) total score

The GSRS is a 15-item interview-based rating scale. Each item is assessed in a seven-point graded Likert-type scale (one means no symptoms, and seven represents very troublesome symptoms), then total score is calculated.

Time frame: At week 1, 2, 3 and 4 from baseline.

Change in KIDSCREEN-10 index total score

KIDSCREEN-10 index is a 11-item instrument to assess health-related quality of life (HRQoL). Each item is assessed in a 5-point scale with higher values indicating a higher HRQoL. Total score is calculated.

Data from ClinicalTrials.gov

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