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

NCT ID: NCT04054349

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2019-07-30

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low FODMAP Diet Group

The parent/caregiver was given detailed nutrition education by the investigator concerning the low FODMAP diet and was asked to implement for 2 weeks.

Group Type: EXPERIMENTAL

Low FODMAP diet

Intervention Type: OTHER

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

Control Group (Habitual Diet)

The parent/caregiver was asked to continue their child's usual dietary intake for 2 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low FODMAP diet

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Marcia Nahikian-Nelms

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcia Nahikian-Nelms, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Nisonger Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2018H0543

Identifier Type: -

Identifier Source: org_study_id