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

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

Conditions

• Autism Spectrum Disorder
• Functional Gastrointestinal Disorders

Interventions

DIETARY_SUPPLEMENT

Probiotic

A probiotic supplement in capsule form containing 4 strains of microorganisms, with a total of 10 × 10⁹ CFU (colony-forming units) per capsule. The strain composition per capsule was: Lactobacillus acidophilus L1 - 2.9 × 10⁹ CFU, Bifidobacterium longum LBL-01 - 2.9 × 10⁹ CFU, Lactobacillus rhamnosus - 2.9 × 10⁹ CFU, Saccharomyces boulardii - 1.3 × 10⁹ CFU. Each participant in this arm took one capsule per day in the morning on a full stomach, for a duration of 4 weeks. No other dietary interventions were applied to this group. This probiotic supplement was chosen because the strains in its content are among the most frequently researched and known strains in terms of intestinal health. Additionally, it does not contain FOS or inulin due to FODMAP restriction. .

OTHER

Low-FODMAP Diet

A structured low-FODMAP diet intervention designed to restrict intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. The diet was individualized and monitored by a registered dietitian over a 4-week period to ensure adherence and nutritional adequacy.

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University

  collaborator OTHER

• Marmara University Pendik Training and Research Hospital

  lead OTHER

Principal Investigators

• Pınar Polat, PhD · Marmara University Pendik Training and Research Hospital

• Neşe Perdahlı Fiş, Prof Dr · Marmara University Pendik Training and Research Hospital

• Özlem Aytekin, AProf Dr · Saglik Bilimleri Universitesi

• Fatih Özbey, Prof Dr · Saglik Bilimleri Universitesi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2024-03-01

Completion

2024-03-01

Countries

• Turkey (Türkiye)

Study Locations