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

NCT04054349 | Completed

• 1 other identifier: 2018H0543
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of stool consistency

  2 weeks

• Assessment of stool frequency

  2 weeks

• Assessment of behavioral problems

  2 weeks

• Energy and Nutrient Intake

  2 weeks

Study Arms (2)

Low FODMAP Diet Group

EXPERIMENTAL

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

Control Group (Habitual Diet)

NO INTERVENTION

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

Interventions

Low FODMAP diet OTHER

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

Low FODMAP Diet Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Nisonger Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Marcia Nahikian-Nelms, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 13, 2019
• Study Start: January 3, 2019
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

US (1)