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

NCT04528914 | Terminated DMC

• 1 other identifier: 1W44/5FNUT13/20
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Abdominal Pain Disorder

Keywords

functional abdominal pain disorders; irritable bowel syndrome; diet

Outcome Measures

Primary Outcomes (1)

• 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).

  At week 1, 2, 3 and 4 from baseline.

Secondary Outcomes (11)

• Change in stool consistency

  At week 1, 2, 3 and 4 from baseline.

• Change in abdominal pain frequency

  At week 1, 2, 3 and 4 from baseline.

• Change in Gastrointestinal Symptom Rating Scale (GSRS) total score

  At week 1, 2, 3 and 4 from baseline.

• Change in KIDSCREEN-10 index total score

  At week 1, 2, 3 and 4 from baseline.

• Change in World Health Organization Five Well-Being Index (WHO-5) total score

  At week 1, 2, 3 and 4 from baseline.

Study Arms (2)

Low-FODMAP diet

EXPERIMENTAL

37 participants.

Other: Low-FODMAP diet

Regular diet

NO INTERVENTION

37 participants. The regular diet will reflect the habitual FODMAP intake in a normal diet. Diets in both groups will be matched in terms of total energy, fat, protein, carbohydrates and dietary fiber with the usual participant's diet.

Interventions

Low-FODMAP diet OTHER

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).

Low-FODMAP diet

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Nutricia Foundation: collaborator

Study Sites (1)

Department of Paediatrics, The Medical University of Warsaw

Warsaw, Poland

Location

Related Publications (1)

• 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.

  PMID: 33388067 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research investigators, outcome assessor, and independent statistician (data analyst) will be blinded until the completion of the data analysis.The dietitian will remain unblinded. Success of blinding will be assessed after completion of the follow-up period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 27, 2020
• Study Start: April 2, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Up to 3 years after completion of data analysis.
• Access Criteria: The datasets will be made available from the contact author upon reasonable request.

Locations

PL (1)