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

NCT07086157 | Completed

• 1 other identifier: 09.2023.1132
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Autism Spectrum Disorder; Functional Gastrointestinal Disorders

Keywords

autism spectrum disorder; probiotics; gut microbiota; low FODMAP diet; gastrointestinal symptoms

Outcome Measures

Primary Outcomes (6)

• Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score

  Change in caregiver-reported irritability scores as measured by the Aberrant Behavior Checklist Irritability Subscale, a standardized behavioral rating scale.

  Baseline and after 4 weeks of intervention

• Change in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score

  Change in hyperactivity scores, as assessed by the caregiver-completed Hyperactivity Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.

  Baseline and after 4 weeks of intervention

• Change in Aberrant Behavior Checklist (ABC) Lethargy-Social Withdrawal Subscale Score

  Change in lethargy-social withdrawal scores, as assessed by the caregiver-completed Lethargy-Social Withdrawal Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.

  Baseline and after 4 weeks of intervention

• Change in Aberrant Behavior Checklist (ABC) Stereotypy Subscale Score

  Change in stereotypy scores, as assessed by the caregiver-completed Stereotypy Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.

  Baseline and after 4 weeks of intervention

• Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score

  Change in inappropriate speech scores, as assessed by the caregiver-completed Inappropriate Speech Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.

  Baseline and after 4 weeks of intervention

• Change in Presence of Functional Gastrointestinal Symptoms as Measured by the QPGS-RIII

  Change in the presence of any functional gastrointestinal symptoms as determined by caregiver responses to the Pediatric Gastrointestinal Symptoms Questionnaire - Rome III (QPGS-RIII), a validated diagnostic tool for functional gastrointestinal disorders in children.

  Baseline and after 4 weeks of intervention

Secondary Outcomes (3)

• Change in Gut Microbiota Alpha Diversity (Shannon Index)

  Baseline and after 4 weeks of intervention

• Change in Gut Microbiota Beta Diversity (UniFrac Analysis)

  Baseline and after 4 weeks of intervention

• Change in Relative Abundance of Specific Bacterial Genera

  Baseline and after 4 weeks of intervention

Study Arms (2)

Low-FODMAP Diet + Probiotic Supplement

EXPERIMENTAL

Participants in this arm received the same probiotic supplement as the other group once daily for 4 weeks, in combination with a personalized low-FODMAP diet. The diet was planned and monitored by a registered dietitian to ensure compliance and nutritional adequacy.

Dietary Supplement: Probiotic; Other: Low-FODMAP Diet

Probiotic Supplement Only

EXPERIMENTAL

Participants in this arm received a multi-strain probiotic supplement containing four bacterial strains (Lactobacillus acidophilus L1, Bifidobacterium longum LBL-01, Lactobacillus rhamnosus, and Saccharomyces boulardii) once daily for 4 weeks. No dietary restrictions or modifications were applied in this group.

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

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. .

Low-FODMAP Diet + Probiotic Supplement; Probiotic Supplement Only

Low-FODMAP Diet OTHER

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.

Low-FODMAP Diet + Probiotic Supplement

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with Autism Spectrum Disorder by a specialist at Marmara University Pendik Training and Research Hospital Child and Adolescent Psychiatry Clinic
• Aged between 6 and 12 years
• Diagnosed with functional gastrointestinal symptoms according to Rome IV criteria
• Willing to participate by signing informed consent and assent forms (by both child and parent)

You may not qualify if:

• Following any other dietary intervention at the time of study initiation
• Routine use of prebiotics or probiotics
• Use of antibiotics within the 4 weeks prior to the study
• Presence of active diarrhea due to intestinal infection or similar condition
• Diagnosis of other gastrointestinal diseases besides functional GI symptoms

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead
• Istanbul Saglik Bilimleri University: collaborator

Study Sites (1)

Marmara Univesity Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

• Lee JC, Chen CM, Sun CK, Tsai IT, Cheng YS, Chiu HJ, Wang MY, Tang YH, Hung KC. The therapeutic effects of probiotics on core and associated behavioral symptoms of autism spectrum disorders: a systematic review and meta-analysis. Child Adolesc Psychiatry Ment Health. 2024 Dec 19;18(1):161. doi: 10.1186/s13034-024-00848-3.

  PMID: 39702309 BACKGROUND

• Iglesias-Vazquez L, Van Ginkel Riba G, Arija V, Canals J. Composition of Gut Microbiota in Children with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Nutrients. 2020 Mar 17;12(3):792. doi: 10.3390/nu12030792.

  PMID: 32192218 BACKGROUND

• Srikantha P, Mohajeri MH. The Possible Role of the Microbiota-Gut-Brain-Axis in Autism Spectrum Disorder. Int J Mol Sci. 2019 Apr 29;20(9):2115. doi: 10.3390/ijms20092115.

  PMID: 31035684 BACKGROUND

• Settanni CR, Bibbo S, Ianiro G, Rinninella E, Cintoni M, Mele MC, Cammarota G, Gasbarrini A. Gastrointestinal involvement of autism spectrum disorder: focus on gut microbiota. Expert Rev Gastroenterol Hepatol. 2021 Jun;15(6):599-622. doi: 10.1080/17474124.2021.1869938. Epub 2021 Jan 5.

  PMID: 33356668 BACKGROUND

• Socala K, Doboszewska U, Szopa A, Serefko A, Wlodarczyk M, Zielinska A, Poleszak E, Fichna J, Wlaz P. The role of microbiota-gut-brain axis in neuropsychiatric and neurological disorders. Pharmacol Res. 2021 Oct;172:105840. doi: 10.1016/j.phrs.2021.105840. Epub 2021 Aug 24.

  PMID: 34450312 BACKGROUND

• Martinez-Gonzalez AE, Andreo-Martinez P. The Role of Gut Microbiota in Gastrointestinal Symptoms of Children with ASD. Medicina (Kaunas). 2019 Jul 26;55(8):408. doi: 10.3390/medicina55080408.

  PMID: 31357482 BACKGROUND

• Leader G, Abberton C, Cunningham S, Gilmartin K, Grudzien M, Higgins E, Joshi L, Whelan S, Mannion A. Gastrointestinal Symptoms in Autism Spectrum Disorder: A Systematic Review. Nutrients. 2022 Apr 1;14(7):1471. doi: 10.3390/nu14071471.

  PMID: 35406084 BACKGROUND

Related Links

• Full-text thesis record in the Turkish National Thesis Center. The thesis no is 888255.

MeSH Terms

Conditions

Autism Spectrum Disorder; Gastrointestinal Diseases

Interventions

Probiotics; FODMAP Diet

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Elimination Diets; Diet; Nutritional Physiological Phenomena

Study Officials

• Pınar Polat, PhD

  Marmara University Pendik Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Neşe Perdahlı Fiş, Prof Dr

  Marmara University Pendik Training and Research Hospital

  STUDY CHAIR

• Özlem Aytekin, AProf Dr

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

• Fatih Özbey, Prof Dr

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

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: Doctor Dietitian

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 25, 2025
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 2 years after the publication of results.
• Access Criteria: Individual participant data (IPD), including raw sequence data, will be shared with qualified researchers upon reasonable request. Raw 16S rRNA sequencing data are publicly available through the National Library of Medicine's Sequence Read Archive (SRA) under accession number \[PRJNA1112427\]. Other IPD can be requested for methodologically sound research purposes by submitting a proposal to the principal investigator. Requests will be reviewed for scientific validity and ethical compliance. Data will be shared via secure transfer after approval and signing a data use agreement.

Locations

TU (1)