Functional Abdominal Pain DisorderNCT04528914
Low-FODMAP Diet for Functional Abdominal Pain Disorders in Children.
A study testing Low-FODMAP diet in people with Functional Abdominal Pain Disorder, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Functional Abdominal Pain Disorder
- What is being tested?
- Low-FODMAP diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePoland
- Study dates
- 2 Apr 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Paediatrics, The Medical University of Warsaw
Warsaw
About this study
Official title: Effect of a Low-FODMAP Diet for the Management of Functional Abdominal Pain Disorders in Children
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.
Read the 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).
- Conditions
- Functional Abdominal Pain Disorder
- Being tested
- Low-FODMAP diet
- Keywords
- functional abdominal pain disorders, irritable bowel syndrome, diet
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Low-FODMAP diet | Experimental | 37 participants. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At week 1, 2, 3 and 4 from baseline.
Secondary outcomes (11)
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].
Measured: At week 1, 2, 3 and 4 from baseline.
Change in abdominal pain frequency
Measured: 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.
Measured: 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.
Measured: At week 1, 2, 3 and 4 from baseline.
Change in World Health Organization Five Well-Being Index (WHO-5) total score
The WHO-5 consists of five statements regarding the physical well-being, assessed in a six-point scale (in which zero means at no time, and five represents all of the time). Total raw score is then calculated, ranging from 0 to 25 which is multiplied by four, therefore the final score ranges from 0 (the worst imaginable well-being) to 100 (the best imaginable well-being).
Measured: At week 1, 2, 3 and 4 from baseline.
Change in percentage of school attendance associated with IBS symptoms
Measured: At week 1, 2, 3 and 4 from baseline.
Change in percentage of parents' work absenteeism associated with IBS symptoms in child
Measured: At week 1, 2, 3 and 4 from baseline.
Change in BMI-for-age z-score
The body weight (kg) and standing height (cm) will be measured following standard methods. Body Mass Index (BMI) will be calculated using the standard equation. BMI-for-age z-score will be computed using the WHO AnthroPlus software v1.0.4., then assessed and monitored over time using the WHO growth charts.
Measured: At week 2 and 4 from baseline.
Percentage of compliant participants
The percentage compliance in each group will be calculated. A compliant participant is considered as one who consumes at least 80% of the provided diet.
The percent of each meal which the subject consumed (<50%, 50-79% or 80-100%) each day will be reported by participant in a study diary (developed by research team); the additional snacks consumed also will be reported daily (characteristics and amount). Snacks and meals outside the meal plan will be assessed separately.
Measured: 0-4 weeks.
Percentage of tolerability of the low-FODMAP diet
The tolerability (acceptability) of the diet will be assessed each day using a 100-mm Visual Analogue Scale and reported in the subject diary. This outcome will be reported as a mean for each study group, and as a comparison between groups.
Measured: 0-4 weeks.
Adverse events
The number of all adverse events and the number of participants reporting adverse events associated with the intervention.
Measured: 0-4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start2 Apr 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Why it stopped: Preliminary results found that there is no difference on abdominal pain intensity between low-FODMAP and regular diet at 4 weeks. Moreover, both diets were difficult to adhere by patients. We do not expect any significant change in our findings.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional Abdominal Pain DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528914
- Sponsor's protocol ID
- 1W44/5FNUT13/20
- Status last verified
- Feb 2025
- First submitted
- 19 Aug 2020
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or generated during this study will be made available after the publication of results, no later than 3 years from the completion of data analysis.
Publications
Strozyk A, Horvath A, Kozlowska-Jalowska A, Muir J, Szajewska H. Efficacy of a low-FODMAP diet in children with irritable bowel syndrome and functional abdominal pain-not otherwise specified: a randomized controlled trial with early termination. Front Pediatr. 2026 Mar 18;14:1809053. doi: 10.3389/fped.2026.1809053. eCollection 2026.
PubMed 41929915Strozyk 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.
PubMed 33388067
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low-FODMAP Diet for the Management of Functional Abdominal Pain Disorders in Children
- ClinicalTrials.gov ID
- NCT04528914
- Acronym / sponsor ID
- 1W44/5FNUT13/20
- Conditions
- Functional Abdominal Pain Disorder
- Keywords
- functional abdominal pain disorders, irritable bowel syndrome, diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary results found that there is no difference on abdominal pain intensity between low-FODMAP and regular diet at 4 weeks. Moreover, both diets were difficult to adhere by patients. We do not expect any significant change in our findings.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Nutricia Foundation
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-FODMAP diet | Experimental | Other: Low-FODMAP diet37 participants. |
| 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-FODMAP dietThe 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). | Other | Low-FODMAP diet |
Primary outcome
Change in abdominal pain intensity
Time frame: At week 1, 2, 3 and 4 from baseline.
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).
11 secondary outcomes
Change in stool consistency
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
Time frame: At week 1, 2, 3 and 4 from baseline.
Change in KIDSCREEN-10 index total score
Time frame: At week 1, 2, 3 and 4 from baseline.
Change in World Health Organization Five Well-Being Index (WHO-5) total score
Time frame: At week 1, 2, 3 and 4 from baseline.
Change in percentage of school attendance associated with IBS symptoms
Time frame: At week 1, 2, 3 and 4 from baseline.
Change in percentage of parents' work absenteeism associated with IBS symptoms in child
Time frame: At week 1, 2, 3 and 4 from baseline.
Change in BMI-for-age z-score
Time frame: At week 2 and 4 from baseline.
Percentage of compliant participants
Time frame: 0-4 weeks.
Percentage of tolerability of the low-FODMAP diet
Time frame: 0-4 weeks.
Adverse events
Time frame: 0-4 weeks.
Results and safety
The study was stopped early (reason given: Preliminary results found that there is no difference on abdominal pain intensity between low-FODMAP and regular diet at 4 weeks. Moreover, both diets were difficult to adhere by patients. We do not expect any significant change in our findings.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Derived from this study: PubMed 41929915Strozyk A, Horvath A, Kozlowska-Jalowska A, Muir J, Szajewska H. Efficacy of a low-FODMAP diet in children with irritable bowel syndrome and functional abdominal pain-not otherwise specified: a randomized controlled trial with early termination. Front Pediatr. 2026 Mar 18;14:1809053. doi: 10.3389/fped.2026.1809053. eCollection 2026.
- Derived from this study: PubMed 33388067Strozyk 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.
- Individual participant dataSharing planned: Yes. The datasets used and/or generated during this study will be made available after the publication of results, no later than 3 years from the completion of data analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-FODMAP diet in people with Functional Abdominal Pain Disorder, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Preliminary results found that there is no difference on abdominal pain intensity between low-FODMAP and regular diet at 4 weeks. Moreover, both diets were difficult to adhere by patients. We do not expect any significant change in our findings.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in abdominal pain intensity (time frame: At week 1, 2, 3 and 4 from baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04528914, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.