Status:
COMPLETED
The Effect of the Low Fodmap Diet in Children With Autism Spectrum Disorders
Lead Sponsor:
Ohio State University
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
6-17 years
Phase:
NA
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 auti...
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 af...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04054349
Start Date
January 3 2019
End Date
July 30 2019
Last Update
August 13 2019
Active Locations (1)
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1
The Ohio State University Nisonger Center
Columbus, Ohio, United States, 43210