Back to resultsLow-FODMAP Diet for FAPD in Children.
Primary Purpose
Functional Abdominal Pain Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Low-FODMAP diet
Sponsored by
About this trial
This is an interventional treatment trial for Functional Abdominal Pain Disorder focused on measuring functional abdominal pain disorders, irritable bowel syndrome, diet
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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),
- 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.
Sites / Locations
- Department of Paediatrics, The Medical University of Warsaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Low-FODMAP diet
Regular diet
Arm Description
37 participants.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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].
Change in abdominal pain frequency
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.
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.
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).
Change in percentage of school attendance associated with IBS symptoms
Change in percentage of parents' work absenteeism associated with IBS symptoms in child
Change in BMI-for-age z-score
The BW (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.
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.
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.
Adverse events
The number of all adverse events and the number of participants reporting adverse events associated with the intervention.
Full Information
NCT ID
NCT04528914
First Posted
August 19, 2020
Last Updated
August 24, 2020
Sponsor
Medical University of Warsaw
Collaborators
Nutricia Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04528914
Brief Title
Low-FODMAP Diet for FAPD in Children.
Official Title
Effect of a Low-FODMAP Diet for the Management of Functional Abdominal Pain Disorders in Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
Collaborators
Nutricia Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Pain Disorder
Keywords
functional abdominal pain disorders, irritable bowel syndrome, diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The research investigators, outcome assessor, and independent statistician (data analyst) will be blinded until the completion of the data analysis.The dietitian will remain unblinded. Success of blinding will be assessed after completion of the follow-up period.
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-FODMAP diet
Arm Type
Experimental
Arm Description
37 participants.
Arm Title
Regular diet
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low-FODMAP diet
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in abdominal pain intensity
Description
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).
Time Frame
At week 1, 2, 3 and 4 from baseline.
Secondary Outcome Measure Information:
Title
Change in stool consistency
Description
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].
Time Frame
At week 1, 2, 3 and 4 from baseline.
Title
Change in abdominal pain frequency
Time Frame
At week 1, 2, 3 and 4 from baseline.
Title
Change in Gastrointestinal Symptom Rating Scale (GSRS) total score
Description
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.
Time Frame
At week 1, 2, 3 and 4 from baseline.
Title
Change in KIDSCREEN-10 index total score
Description
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.
Time Frame
At week 1, 2, 3 and 4 from baseline.
Title
Change in World Health Organization Five Well-Being Index (WHO-5) total score
Description
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).
Time Frame
At week 1, 2, 3 and 4 from baseline.
Title
Change in percentage of school attendance associated with IBS symptoms
Time Frame
At week 1, 2, 3 and 4 from baseline.
Title
Change in percentage of parents' work absenteeism associated with IBS symptoms in child
Time Frame
At week 1, 2, 3 and 4 from baseline.
Title
Change in BMI-for-age z-score
Description
The BW (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.
Time Frame
At week 2 and 4 from baseline.
Title
Percentage of compliant participants
Description
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.
Time Frame
0-4 weeks.
Title
Percentage of tolerability of the low-FODMAP diet
Description
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.
Time Frame
0-4 weeks.
Title
Adverse events
Description
The number of all adverse events and the number of participants reporting adverse events associated with the intervention.
Time Frame
0-4 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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),
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agata Stróżyk, MSc
Phone
22 317 95 39
Ext
+48
Email
ag.strozyk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Horvath, MD, PhD
Phone
22 317 95 39
Ext
+48
Email
andrea.hania@gmail.com
Facility Information:
Facility Name
Department of Paediatrics, The Medical University of Warsaw
City
Warsaw
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Horvath, MD, PhD
Phone
22 317 95 39
Ext
+48
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Up to 3 years after completion of data analysis.
IPD Sharing Access Criteria
The datasets will be made available from the contact author upon reasonable request.
Citations:
PubMed Identifier
33388067
Citation
Strozyk 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.
Results Reference
derived
Learn more about this trial
Low-FODMAP Diet for FAPD in Children.
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