An interventional study of Low FODMAP diet in Autism Spectrum Disorder, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 15 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
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Exclusion Criteria:
The parent/caregiver was given detailed nutrition education by the investigator concerning the low FODMAP diet and was asked to implement for 2 weeks.
Other: Low FODMAP diet
The parent/caregiver was asked to continue their child's usual dietary intake for 2 weeks.
The low FODMAP diet group reduced the intake of FODMAP(fermentable oligosaccharides, disaccharides, monosaccharides, and polyols)
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).
Time frame: 2 weeks
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.
Time frame: 2 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.
Time frame: 2 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.
Time frame: 2 weeks
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
Time frame: 2 weeks
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Ohio State University