Back to resultsThe Effect of the Low Fodmap Diet in Children With Autism Spectrum Disorders
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low FODMAP diet
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- 6-17 age range
- Diagnosed with autism spectrum disorder
- Parent/Caregiver report of constipation and /or abdominal pain. • ROME IV criteria was utilized to identify constipation (defined as the presence of two of more of the following symptoms: Two or fewer stools per week, at least 1 episode of fecal incontinence per week, history of retentive posturing or excessive volitional stool retention, history of painful or hard bowel movements, presence of a large fecal mass in the rectum, history of large diameter stools that can obstruct the toilet) • ROME IV criteria was utilized to identify abdominal pain (defined as the fulfilled at least 4 times per month and include all of the following: episodic or continuous abdominal pain that does not occur solely during physiologic events (eg, eating, menses), insufficient criteria for irritable bowel syndrome, functional dyspepsia, or abdominal migraine, the abdominal pain cannot be fully explained by another medical condition)
Exclusion Criteria:
- Under 6 and over 17 years old
- Having a specific restrictive diet to treat allergies or a specific chronic disease - Any history of abdominal surgeries
- Any history of chronic physiological GI disorders such as celiac, inflammatory bowel disease, eosinophilic esophagitis.
- Any chronic condition that may impact GI function such as thyroid disease, cystic fibrosis, or cardiac abnormalities
Sites / Locations
- The Ohio State University Nisonger Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Low FODMAP Diet Group
Control Group (Habitual Diet)
Arm Description
The parent/caregiver was given detailed nutrition education by the investigator concerning the low FODMAP diet and was asked to implement for 2 weeks.
The parent/caregiver was asked to continue their child's usual dietary intake for 2 weeks.
Outcomes
Primary Outcome Measures
Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Module-Parent Report
Before the study period and at the end of the two weeks, the effect of the low FODMAP diet on the severity of GI disorders was assessed with the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Module-Parent Report. A 74-item survey with 14 scales items: stomach pain and hurt (6 items), discomfort when eating (5), food and drink limits (6), trouble swallowing (3), heartburn/reflux (4), nausea/vomiting (4), gas and bloating (7), constipation (14), blood in poop (2), diarrhea (7), worry about going poop (5), worry about stomachaches (2), medicines (4), and communication (5). Total Score: Sum of all the items over the number of items answered on all the Scales. Items are reverse-scored and transformed to a 0-100 scale so lower scores reflect worse GI dysfunction (As follows: 0=100, 1=75, 2=50, 3=25, 4=0). Response choices are in Likert-scale format ranging from 0 to 4 (0=Never, 1=Almost Never, 2=Sometimes, 3=Often, 4=Almost Always).
Secondary Outcome Measures
Assessment of stool consistency
Consistency of the stool were recorded for 3 days before the study period and the last three days of the study using the Bristol stool scale. According to Bristol stool scale human stool is categorized into seven groups. Types 1 and 2 are defined as indications of constipation, Types 6 and 7 are indications of diarrhea, and Types 3, 4, and 5 show normal stool consistency. Daily stool consistency score was recorded. This was averaged and compared to the baseline and two weeks.
Assessment of stool frequency
Frequency of the stool were recorded for 3 days before the study period and the last three days of the study. Daily number of stools were recorded. This was averaged and compared to the baseline and two weeks.
Assessment of behavioral problems
Behavioral problems were determined before the study period and end of the study (after two weeks) using the Aberrant Behavior Checklist-Community (ABC-C). ABC-C checklist have 5 domains: 1) Irritability (includes agitation, aggression and self-injurious behaviors, 15 items); 2) Social Withdrawal (16 items); 3) Stereotypies (7 items); 4) Hyperactivity (16 items); and 5)Inappropriate Speech (4 items).The ABC-C is a 58-item questionnaire for caregivers/parent/caregivers and each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), 3 (severe problem). it is not computed a total score based on the summation of all 58 items, as the subscales are largely independents. Higher scores indicate a higher severity of behavioral problems.
Energy and Nutrient Intake
The parent/caregiver recorded food consumption of children for three days before the study period and the last three days of the study.The data for the three day dietary record were entered into a computerized database. Energy, macronutrients and micronutrients were calculated using The Food Processor SQL - ESHA Research. 2006
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04054349
Brief Title
The Effect of the Low Fodmap Diet in Children With Autism Spectrum Disorders
Official Title
The Effect of the Low Fodmap Diet on Gastrointestinal and Behavioral Problems in Children With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study assesses the effect of the low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet on gastrointestinal (GI) and behavioral problems in children with autism spectrum disorder (ASD). The objectives of this study are: -To determine whether the low FODMAP diet causes a decrease in gastrointestinal problems related to ASD -To determine whether the low FODMAP diet causes a decrease in behavioral problems -To assess the effect of decreased gastrointestinal problems on reduction of behavioral problems
Detailed Description
In this study, participants were children with autism spectrum disorder (ASD) ages 6-17 years. Children with ASD were randomized to the low FODMAP diet or habitual diet for 2 weeks. At baseline and after a two-week intervention period, the parent/caregiver completed the Aberrant Behavior Checklist-Community and Pediatric Quality of Life Inventory Gastrointestinal Module. The parent/caregiver also completed a dietary food record, and stool consistency/frequency record (three days before start to intervention and the last three days of the intervention) of their children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low FODMAP Diet Group
Arm Type
Experimental
Arm Description
The parent/caregiver was given detailed nutrition education by the investigator concerning the low FODMAP diet and was asked to implement for 2 weeks.
Arm Title
Control Group (Habitual Diet)
Arm Type
No Intervention
Arm Description
The parent/caregiver was asked to continue their child's usual dietary intake for 2 weeks.
Intervention Type
Other
Intervention Name(s)
Low FODMAP diet
Intervention Description
The low FODMAP diet group reduced the intake of FODMAP(fermentable oligosaccharides, disaccharides, monosaccharides, and polyols)
Primary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Module-Parent Report
Description
Before the study period and at the end of the two weeks, the effect of the low FODMAP diet on the severity of GI disorders was assessed with the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Module-Parent Report. A 74-item survey with 14 scales items: stomach pain and hurt (6 items), discomfort when eating (5), food and drink limits (6), trouble swallowing (3), heartburn/reflux (4), nausea/vomiting (4), gas and bloating (7), constipation (14), blood in poop (2), diarrhea (7), worry about going poop (5), worry about stomachaches (2), medicines (4), and communication (5). Total Score: Sum of all the items over the number of items answered on all the Scales. Items are reverse-scored and transformed to a 0-100 scale so lower scores reflect worse GI dysfunction (As follows: 0=100, 1=75, 2=50, 3=25, 4=0). Response choices are in Likert-scale format ranging from 0 to 4 (0=Never, 1=Almost Never, 2=Sometimes, 3=Often, 4=Almost Always).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Assessment of stool consistency
Description
Consistency of the stool were recorded for 3 days before the study period and the last three days of the study using the Bristol stool scale. According to Bristol stool scale human stool is categorized into seven groups. Types 1 and 2 are defined as indications of constipation, Types 6 and 7 are indications of diarrhea, and Types 3, 4, and 5 show normal stool consistency. Daily stool consistency score was recorded. This was averaged and compared to the baseline and two weeks.
Time Frame
2 weeks
Title
Assessment of stool frequency
Description
Frequency of the stool were recorded for 3 days before the study period and the last three days of the study. Daily number of stools were recorded. This was averaged and compared to the baseline and two weeks.
Time Frame
2 weeks
Title
Assessment of behavioral problems
Description
Behavioral problems were determined before the study period and end of the study (after two weeks) using the Aberrant Behavior Checklist-Community (ABC-C). ABC-C checklist have 5 domains: 1) Irritability (includes agitation, aggression and self-injurious behaviors, 15 items); 2) Social Withdrawal (16 items); 3) Stereotypies (7 items); 4) Hyperactivity (16 items); and 5)Inappropriate Speech (4 items).The ABC-C is a 58-item questionnaire for caregivers/parent/caregivers and each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), 3 (severe problem). it is not computed a total score based on the summation of all 58 items, as the subscales are largely independents. Higher scores indicate a higher severity of behavioral problems.
Time Frame
2 weeks
Title
Energy and Nutrient Intake
Description
The parent/caregiver recorded food consumption of children for three days before the study period and the last three days of the study.The data for the three day dietary record were entered into a computerized database. Energy, macronutrients and micronutrients were calculated using The Food Processor SQL - ESHA Research. 2006
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
6-17 age range
Diagnosed with autism spectrum disorder
Parent/Caregiver report of constipation and /or abdominal pain. • ROME IV criteria was utilized to identify constipation (defined as the presence of two of more of the following symptoms: Two or fewer stools per week, at least 1 episode of fecal incontinence per week, history of retentive posturing or excessive volitional stool retention, history of painful or hard bowel movements, presence of a large fecal mass in the rectum, history of large diameter stools that can obstruct the toilet) • ROME IV criteria was utilized to identify abdominal pain (defined as the fulfilled at least 4 times per month and include all of the following: episodic or continuous abdominal pain that does not occur solely during physiologic events (eg, eating, menses), insufficient criteria for irritable bowel syndrome, functional dyspepsia, or abdominal migraine, the abdominal pain cannot be fully explained by another medical condition)
Exclusion Criteria:
Under 6 and over 17 years old
Having a specific restrictive diet to treat allergies or a specific chronic disease - Any history of abdominal surgeries
Any history of chronic physiological GI disorders such as celiac, inflammatory bowel disease, eosinophilic esophagitis.
Any chronic condition that may impact GI function such as thyroid disease, cystic fibrosis, or cardiac abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia Nahikian-Nelms, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Nisonger Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of the Low Fodmap Diet in Children With Autism Spectrum Disorders
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