Clinical trial NCT04528914: Low-FODMAP Diet for Functional Abdominal Pain Disorders in Children.
Official title: Effect of a Low-FODMAP Diet for the Management of Functional Abdominal Pain Disorders in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Functional Abdominal Pain Disorder
Keywords: functional abdominal pain disorders
irritable bowel syndrome
diet
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Nutricia Foundation
First posted: 2020-08-27
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 mean abdominal pain intensity score compared with those who receive a regular diet after 4 weeks of intervention.

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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in abdominal pain intensity
timeFrame: At week 1, 2, 3 and 4 from baseline.
Secondary outcomes:
measure: Change in stool consistency
timeFrame: At week 1, 2, 3 and 4 from baseline.
measure: Change in abdominal pain frequency
timeFrame: At week 1, 2, 3 and 4 from baseline.
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS) total score
timeFrame: At week 1, 2, 3 and 4 from baseline.
measure: Change in KIDSCREEN-10 index total score
timeFrame: At week 1, 2, 3 and 4 from baseline.
measure: Change in World Health Organization Five Well-Being Index (WHO-5) total score
timeFrame: At week 1, 2, 3 and 4 from baseline.
measure: Change in percentage of school attendance associated with IBS symptoms
timeFrame: At week 1, 2, 3 and 4 from baseline.
measure: Change in percentage of parents' work absenteeism associated with IBS symptoms in child
timeFrame: At week 1, 2, 3 and 4 from baseline.
measure: Change in BMI-for-age z-score
timeFrame: At week 2 and 4 from baseline.
measure: Percentage of compliant participants
timeFrame: 0-4 weeks.
measure: Percentage of tolerability of the low-FODMAP diet
timeFrame: 0-4 weeks.
measure: Adverse events
timeFrame: 0-4 weeks.
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Paediatrics, The Medical University of Warsaw
Study officials:
References:
citation: Strozyk A, Horvath A, Muir J, Szajewska H. Effect of a low-FODMAP diet for the management of functional abdominal pain disorders in children: a study protocol for a randomized controlled trial. Nutr J. 2021 Jan 2;20(1):1. doi: 10.1186/s12937-020-00656-3.