NCT07086157Completed
Low-FODMAP Diet and Probiotics: Effects on Gut, Behavior, and Microbiota in Children With Autism Spectrum Disorder
Effects of Low-FODMAP Diet and Probiotics on Gastrointestinal Symptoms, Behavior Problems, and Microbiota in Children With Autism Spectrum Disorder and Gastrointestinal Symptoms
Source: ClinicalTrials.gov · Last updated 25 Jul 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 5 Jul 2025
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Diseases
- Autism
- NCT number
- NCT07086157
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 1 Dec 2023 to the primary completion date, 1 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics within the 4 weeks prior to the study
Other illness
- Presence of active diarrhea due to intestinal infection or similar condition
- Diagnosis of other gastrointestinal diseases besides functional GI symptoms
Other
- Following any other dietary intervention at the time of study initiation
- Routine use of prebiotics or probiotics
Who the study is looking for
- 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)
Age in the registry: 6 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Marmara Univesity Pendik Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.