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

Last updated: August 9, 2019
Sponsor: Ohio State University
Overall Status: Completed

Phase

N/A

Condition

Autism

Asperger's Disorder

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT04054349
2018H0543
  • Ages 6-17
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 6-17 age range

  • Diagnosed with autism spectrum disorder

  • Parent/Caregiver report of constipation and /or abdominal pain. • ROME IV criteria wasutilized to identify constipation (defined as the presence of two of more of thefollowing symptoms: Two or fewer stools per week, at least 1 episode of fecalincontinence per week, history of retentive posturing or excessive volitional stoolretention, history of painful or hard bowel movements, presence of a large fecal massin the rectum, history of large diameter stools that can obstruct the toilet) • ROMEIV 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 abdominalpain that does not occur solely during physiologic events (eg, eating, menses),insufficient criteria for irritable bowel syndrome, functional dyspepsia, or abdominalmigraine, the abdominal pain cannot be fully explained by another medical condition)

Exclusion

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 boweldisease, eosinophilic esophagitis.

  • Any chronic condition that may impact GI function such as thyroid disease, cysticfibrosis, or cardiac abnormalities

Study Design

Total Participants: 15
Study Start date:
January 03, 2019
Estimated Completion Date:
July 30, 2019

Study 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.

Connect with a study center

  • The Ohio State University Nisonger Center

    Columbus, Ohio 43210
    United States

    Site Not Available

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