The Effect of the Low Fodmap Diet in Children With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

Official title:

The Effect of the Low Fodmap Diet on Gastrointestinal and Behavioral Problems in Children With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054349
• Other study ID #: 2018H0543
• Status: Completed
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2019
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Other:
• Low FODMAP diet
The low FODMAP diet group reduced the intake of FODMAP(fermentable oligosaccharides, disaccharides, monosaccharides, and polyols)

Locations

Country	Name	City	State
United States	The Ohio State University Nisonger Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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	2 weeks