Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.
NCT ID: NCT03771027
Last Updated: 2018-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
33 participants
INTERVENTIONAL
2017-07-08
2017-12-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low FODMAP diet group
four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.
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.
Control group
four weeks of the diet based on NICE guidelines and contained products with different FODMAP content
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* consent to participate in the study
* positive decision of gastroenterologist concerning enrolment of the patient to the trial
Exclusion Criteria
* occurrence of an abdominal migraine, IBS, food allergies or intolerances, other significant disorders, acute infection
* antibiotic treatment within the last 8 weeks
5 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Science Centre, Poland
OTHER_GOV
University of Warmia and Mazury
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Katarzyna Boradyn
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katarzyna M Boradyn, MSc
Role: PRINCIPAL_INVESTIGATOR
Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
Elżbieta Jarocka-Cyrta, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum Faculty of Medicine, University of Warmia and Mazury
Katarzyna E Przybyłowicz, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Regional Specialized Children's Hospital
Olsztyn, , Poland
University of Warmia and Mazury
Olsztyn, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015/17/N/NZ5/02596
Identifier Type: -
Identifier Source: org_study_id