Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.
Primary Purpose
Functional Abdominal Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
The low FODMAP diet.
The diet based on NICE guidelines.
Sponsored by
About this trial
This is an interventional treatment trial for Functional Abdominal Pain Syndrome focused on measuring low FODMAP diet, functional abdominal pain, children
Eligibility Criteria
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
Sites / Locations
- Regional Specialized Children's Hospital
- University of Warmia and Mazury
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low FODMAP diet group
Control group
Arm Description
four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.
four weeks of the diet based on NICE guidelines and contained products with different FODMAP content
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Assessment of abdominal pain and defecation frequency
Abdominal pain and defecation frequency were recorded as number per day.
Full Information
NCT ID
NCT03771027
First Posted
December 6, 2018
Last Updated
December 7, 2018
Sponsor
University of Warmia and Mazury
Collaborators
National Science Centre, Poland
1. Study Identification
Unique Protocol Identification Number
NCT03771027
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 8, 2017 (Actual)
Primary Completion Date
December 8, 2017 (Actual)
Study Completion Date
December 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Warmia and Mazury
Collaborators
National Science Centre, Poland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Pain Syndrome
Keywords
low FODMAP diet, functional abdominal pain, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low FODMAP diet group
Arm Type
Experimental
Arm Description
four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
four weeks of the diet based on NICE guidelines and contained products with different FODMAP content
Intervention Type
Other
Intervention Name(s)
The low FODMAP diet.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The diet based on NICE guidelines.
Intervention Description
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 Outcome Measure Information:
Title
Assessment of abdominal pain severity
Description
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)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Assessment of abdominal pain and defecation frequency
Description
Abdominal pain and defecation frequency were recorded as number per day.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Assessment of stool consistency
Description
Stool consistency was assessed using the validated Bristol Stool Form Scale. Type 1 or 2 were classified as the hard or lumpy stool, type 6 or 7 as the loose or waterly stool, and type 3-5 as the normal stool.
Time Frame
6 weeks
Title
Assessment of nutritional status
Description
Parameters of nutritional status before diet: weight (kilograms), height (meters).
Time Frame
4 months
Title
Assessment of physical activity
Description
The level of physical activity was established used the MVPA indicator (Moderate to Vigorous Physical Activity)
Time Frame
4 months
Title
Assessment of well-being of the patient
Description
Declarations of parents about symptoms changes in children during diet intervention based on a seven-point Likert scale (from 'much worse' to 'never occurred')
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna M Boradyn, MSc
Organizational Affiliation
Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elżbieta Jarocka-Cyrta, Ph.D
Organizational Affiliation
Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum Faculty of Medicine, University of Warmia and Mazury
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katarzyna E Przybyłowicz, Ph.D
Organizational Affiliation
Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Specialized Children's Hospital
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
University of Warmia and Mazury
City
Olsztyn
ZIP/Postal Code
10-719
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.
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