---
title: Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.
nct_id: NCT03771027
overall_status: COMPLETED
phase: NA
sponsor: University of Warmia and Mazury
study_type: INTERVENTIONAL
primary_condition: Functional Abdominal Pain Syndrome
countries: Poland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03771027.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03771027"
ct_last_update_post_date: 2018-12-10
last_seen_at: "2026-05-12T07:02:37.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.

**Official Title:** Evaluation of the Effectiveness of the Low FODMAP Diet in the Treatment of Functional Abdominal Pain in Children

**NCT ID:** [NCT03771027](https://clinicaltrials.gov/study/NCT03771027)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 33
- **Lead Sponsor:** University of Warmia and Mazury
- **Collaborators:** National Science Centre, Poland
- **Conditions:** Functional Abdominal Pain Syndrome
- **Start Date:** 2017-07-08
- **Completion Date:** 2017-12-08
- **CT.gov Last Update:** 2018-12-10

## Brief Summary

Diet components are important factors in pathogenesis of functional gastrointestinal disorders, especially in the irritable bowel syndrome. Fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) are a group of short chain, poorly absorbed and osmotically active carbohydrates, which can induce gastrointestinal symptoms because of rapid fermentation in different segments of the gut. Low FODMAP diet is a novel treatment option with proven efficacy in reducing symptoms of functional gastrointestinal disorders in adults. Conversely, although functional abdominal pain is a common health problem in children, the efficacy of a low FODMAP diet remains understudied in this population.

The aim of this study was to compare the effects of two diets: a low FODMAP diet and a diet based on standard dietary advice of the National Institute for Health and Care Excellence (NICE), on abdominal symptoms in children with functional abdominal pain.

## Eligibility

- **Minimum age:** 5 Years
- **Maximum age:** 12 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* functional abdominal pain according to Rome III criteria
* consent to participate in the study
* positive decision of gastroenterologist concerning enrolment of the patient to the trial

Exclusion Criteria:

* organic causes for gastrointestinal tract disorders,
* occurrence of an abdominal migraine, IBS, food allergies or intolerances, other significant disorders, acute infection
* antibiotic treatment within the last 8 weeks
```

## Arms

- **Low FODMAP diet group** (EXPERIMENTAL) — four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.
- **Control group** (ACTIVE_COMPARATOR) — four weeks of the diet based on NICE guidelines and contained products with different FODMAP content

## Interventions

- **The low FODMAP diet.** (OTHER) — The low FODMAP group had reduced the intake of FODMAP. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.
- **The diet based on NICE guidelines.** (OTHER) — The control group based on NICE guidelines received diet contained products with different FODMAP content. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.

## Primary Outcomes

- **Assessment of abdominal pain severity** _(time frame: 6 weeks)_ — Wong-Baker FACES Pain Rating Scale where 0 = no hurt and 10 = hurts worst was used for assessed severity of abdominal pain during the 6-week study period (2 weeks before and 4 weeks during the diet)

## Secondary Outcomes

- **Assessment of abdominal pain and defecation frequency** _(time frame: 6 weeks)_

## Locations (2)

- Regional Specialized Children's Hospital, Olsztyn, Poland
- University of Warmia and Mazury, Olsztyn, Poland

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.regional specialized children's hospital|olsztyn||poland` — added _(2026-05-12)_
- `locations.university of warmia and mazury|olsztyn||poland` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03771027*  
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