Low-FODMAP Diet and Probiotics: Effects on Gut, Behavior, and Microbiota in Children With Autism Spectrum Disorder

NCT ID: NCT07086157 Phase: NA Status: COMPLETED Enrollment: 16 Completion: 2024-03-01

Conditions

Autism Spectrum Disorder, Functional Gastrointestinal Disorders

Interventions

Probiotic, Low-FODMAP Diet

Summary

The goal of this clinical trial was to evaluate whether a low-FODMAP diet and probiotic supplements could reduce gastrointestinal (GI) symptoms and behavior problems in children with autism spectrum disorder (ASD) who also experienced GI issues. The main questions it aimed to answer were:

Did a low-FODMAP diet and/or probiotics improve GI symptoms such as constipation, diarrhea, and abdominal pain?

Did these interventions help reduce behavior problems such as irritability, lethargy, stereotypy, hyperactivity, and speech disorder ?

Researchers compared two groups:

  1. Children who received a daily probiotic supplement containing 4 strains for 4 weeks
  2. Children who received both the probiotic supplement and followed a low-FODMAP diet

This comparison aimed to determine whether the combination of diet and probiotics had greater benefits than probiotics alone.

Participants:

Took the assigned intervention(s) for 4 weeks

Provided stool samples for gut microbiota analysis

Completed assessments of GI symptoms and behavior using validated questionnaires

Primary Outcome

Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score

Source

ClinicalTrials.gov