Functional Gastrointestinal Disorders in ChildrenPhase 1NCT02117180
Nutritional Adequacy of a FODMAP Diet in Children
A Phase 1 study testing FODMAP's diet in people with Functional Gastrointestinal Disorders in Children, run by Dr Anne Payne at 1 site in United Kingdom.
Trial summary
This pilot study aims to establish whether a low FODMAP diet is safe in children with functional gastrointestinal disorders. The practicality of implementing this diet will be evaluated as well as symptom improvement and quality of life. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Functional Gastrointestinal Disorders in Children
- What is being tested?
- FODMAP's diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Aug 2015
- Phase
- Phase 1
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 10-16 years
- Informed consent and assent obtained
- Patients with diagnosed FGID according to Rome III criteria: i.e. category H2b (irritable bowel syndrome) and H2d (childhood functional abdominal pain)
Who cannot join
- Patients with other gastrointestinal conditions (e.g. coeliac disease, inflammatory bowel disease)
- Patients with food allergies
- Patients with a weight for age below -2 Standard Deviations (SD) (below 0.4th centile) on the UK WHO growth charts.
- Patients with known micronutrient deficiencies determined by blood levels prior to study
- Patients without informed consent and assent obtained
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Chelsea and Westminster NHS Foundation Trust
London, SW10 9NH
Claire de Koker, BSc (Hons), (+44) 208 746 8173, claire.dekoker@chelwest.nhs.uk
Claire de Koker, BSc (Hons)
About this study
Official title: Evaluation of the Nutritional Adequacy of a Diet Low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP's) in Children With Functional Gastrointestinal Disorders.
This pilot study aims to establish whether a low FODMAP diet is safe in children with functional gastrointestinal disorders. The practicality of implementing this diet will be evaluated as well as symptom improvement and quality of life. A larger intervention trial, if deemed appropriate, will then follow to assess symptom efficacy in children.
- Being tested
- FODMAP's diet
- Keywords
- functional gastrointestinal disorders, FGID, children, FODMAP
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FODMAP's dietOther
The safety and efficacy of a low FODMAP diet will be evaluated in a convenience sample of children with functional gastrointestinal disorders, over a 6 week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| FODMAP's diet | Other | A diet low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs) Receives: Other: FODMAP's diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy and nutrient intake
Energy and nutrient intake will be assessed using a 4-day estimated food diary at baseline and 6-weeks after dietary intervention. Comparison will be made between baseline and 6-week data and with United Kingdom (UK) Reference Nutrient Intakes.
Measured: Baseline, 6 weeks
Secondary outcomes (2)
Practicality of the FODMAP diet; impact of diet on Functional Gastro-Intestinal .Disorders (FGID) symptoms and stools
Practicality of the FODMAP diet will be evaluated using a standardised structured questionnaire.
The impact of a low FODMAP diet on FGID symptoms and stools will be assessed using a validated symptom questionnaire and the Bristol Stool Chart.
The impact of a low FODMAP diet on quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module.
Measured: Baseline, 6 weeks
Anthropometry: weight and mid-arm circumference
Anthropometric measurements will be taken at baseline and 6 weeks after dietary intervention. Comparison will be made between baseline and 6-week data for weight and mid upper arm circumference, as well as comparing both baseline and 6-week data to the UK-WHO growth standards.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal Disorders in ChildrenStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Anne Payne
- Sponsor type
- University, hospital or other
- Collaborators
- University of London
- Responsible party
- Sponsor-investigator, Dr Anne Payne, University of Plymouth
- Investigators
- Anne Payne, PhD, Study director, University of PlymouthClaire de Koker, BSc (Hons), Principal investigator, Chelsea and Westminster NHS Foundation Trust, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117180
- Sponsor's protocol ID
- CdeK2014
- Status last verified
- Jun 2015
- First submitted
- 9 Apr 2014
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Nutritional Adequacy of a Diet Low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP's) in Children With Functional Gastrointestinal Disorders.
- ClinicalTrials.gov ID
- NCT02117180
- Acronym / sponsor ID
- CdeK2014
- Keywords
- functional gastrointestinal disorders, FGID, children, FODMAP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Dr Anne PayneUniversity, hospital or other
- Collaborators
- University of London
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 17 Apr 2014 (estimated)
- 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 pilot study aims to establish whether a low FODMAP diet is safe in children with functional gastrointestinal disorders. The practicality of implementing this diet will be evaluated as well as symptom improvement and quality of life. A larger intervention trial, if deemed appropriate, will then follow to assess symptom efficacy in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FODMAP's diet | Other | Other: FODMAP's dietA diet low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs) |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged 10-16 years
- Informed consent and assent obtained
- Patients with diagnosed FGID according to Rome III criteria: i.e. category H2b (irritable bowel syndrome) and H2d (childhood functional abdominal pain)
Key exclusion criteria (5 listed)
- Patients with other gastrointestinal conditions (e.g. coeliac disease, inflammatory bowel disease)
- Patients with food allergies
- Patients with a weight for age below -2 Standard Deviations (SD) (below 0.4th centile) on the UK WHO growth charts.
- Patients with known micronutrient deficiencies determined by blood levels prior to study
- Patients without informed consent and assent obtained
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 |
|---|---|---|
| FODMAP's dietThe safety and efficacy of a low FODMAP diet will be evaluated in a convenience sample of children with functional gastrointestinal disorders, over a 6 week intervention period. | Other | FODMAP's diet |
Primary outcome
Energy and nutrient intake
Time frame: Baseline, 6 weeks
Energy and nutrient intake will be assessed using a 4-day estimated food diary at baseline and 6-weeks after dietary intervention. Comparison will be made between baseline and 6-week data and with United Kingdom (UK) Reference Nutrient Intakes.
2 secondary outcomes
Practicality of the FODMAP diet; impact of diet on Functional Gastro-Intestinal .Disorders (FGID) symptoms and stools
Time frame: Baseline, 6 weeks
Anthropometry: weight and mid-arm circumference
Time frame: Baseline, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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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.
Anne Payne, PhD study director
University of Plymouth
Claire de Koker, BSc (Hons) principal investigator
Chelsea and Westminster NHS Foundation Trust, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FODMAP's diet in people with Functional Gastrointestinal Disorders in Children, run by Dr Anne Payne at 1 site in United Kingdom.
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 5 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: status not confirmed, as of the sponsor's last update on 4 Jun 2015. 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 United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire de Koker, BSc (Hons) ((+44)208 746 8173, claire.dekoker@chelwest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy and nutrient intake (time frame: Baseline, 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 4 Jun 2015.