Functional Abdominal Pain SyndromeNCT03771027
Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.
A study testing The low FODMAP diet. and The diet based on NICE guidelines. in people with Functional Abdominal Pain Syndrome, run by University of Warmia and Mazury at 2 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Functional Abdominal Pain Syndrome
- What is being tested?
- The low FODMAP diet. and The diet based on NICE guidelines.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesPoland
- Study dates
- 8 Jul 2017to 8 Dec 2017
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Regional Specialized Children's Hospital
Olsztyn, 10-561
University of Warmia and Mazury
Olsztyn, 10-719
About this study
Official title: Evaluation of the Effectiveness of the Low FODMAP Diet in the Treatment of Functional Abdominal Pain in Children
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.
- Conditions
- Functional Abdominal Pain Syndrome
- Being tested
- The low FODMAP diet., The diet based on NICE guidelines.
- Keywords
- low FODMAP diet, functional abdominal pain, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Low FODMAP diet group | Experimental | four weeks of the low FODMAP diet based on Monash University low FODMAP diet App. Receives: Other: The low FODMAP diet. |
| Control group | Active comparator | four weeks of the diet based on NICE guidelines and contained products with different FODMAP content Receives: Other: The diet based on NICE guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of abdominal pain severity
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)
Measured: 6 weeks
Secondary outcomes (1)
Assessment of abdominal pain and defecation frequency
Abdominal pain and defecation frequency were recorded as number per day.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start8 Jul 2017
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Abdominal Pain SyndromeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland
- Responsible party
- Principal investigator, Katarzyna Boradyn, University of Warmia and Mazury
- Investigators
- Katarzyna M Boradyn, MSc, Principal investigator, Department of Human Nutrition, Faculty of Food Science, University of Warmia and MazuryElżbieta Jarocka-Cyrta, Ph.D, Principal investigator, Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum Faculty of Medicine, University of Warmia and MazuryKatarzyna E Przybyłowicz, Ph.D, Principal investigator, Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771027
- Sponsor's protocol ID
- 2015/17/N/NZ5/02596
- Status last verified
- Dec 2018
- First submitted
- 6 Dec 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Low FODMAP Diet in the Treatment of Functional Abdominal Pain in Children
- ClinicalTrials.gov ID
- NCT03771027
- Acronym / sponsor ID
- 2015/17/N/NZ5/02596
- Conditions
- Functional Abdominal Pain Syndrome
- Keywords
- low FODMAP diet, functional abdominal pain, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Warmia and MazuryUniversity, hospital or other
- Collaborators
- National Science Centre, Poland
- Study start
- 8 Jul 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 10 Dec 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low FODMAP diet group | Experimental | Other: The low FODMAP diet.four weeks of the low FODMAP diet based on Monash University low FODMAP diet App. |
| Control group | Active comparator | Other: The diet based on NICE guidelines.four weeks of the diet based on NICE guidelines and contained products with different FODMAP content |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| The low FODMAP diet.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. | Other | Low FODMAP diet group |
| The diet based on NICE guidelines.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. | Other | Control group |
Primary outcome
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)
1 secondary outcome
Assessment of abdominal pain and defecation frequency
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Katarzyna M Boradyn, MSc principal investigator
Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
Elżbieta Jarocka-Cyrta, Ph.D principal investigator
Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum Faculty of Medicine, University of Warmia and Mazury
Katarzyna E Przybyłowicz, Ph.D principal investigator
Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The low FODMAP diet. and The diet based on NICE guidelines. in people with Functional Abdominal Pain Syndrome, run by University of Warmia and Mazury at 2 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of abdominal pain severity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2018.