Autism Diagnostic Interview-Revised: a revised version of a diagnostic interview for caregivers of individuals with possible pervasive developmental disorders.
C Lord, M Rutter, A Le Couteur
https://pubmed.ncbi.nlm.nih.gov/7814313Actively Recruiting
Phase 2
Phase 3
Age: 3Years - 8Years
All Genders
Healthy Volunteers
ID07450443
Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders: Evaluation of Postbiotic-based Nutraceutical Treatment
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-03-04
90
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead Sponsor
I
Istituto Clinico Humanitas
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the role of gut microbiota in Autism Spectrum Disorders (ASD) and the potential benefits of postbiotic-based dietary supplements in children aged 3 to 8 years. ASD is a neurobiological condition with complex causes, often accompanied by gastrointestinal symptoms that may influence the severity of behavioral symptoms. This study aims to explore non-drug treatments to improve gastrointestinal and behavioral symptoms in children with ASD, enhancing clinical management strategies. The study involves three groups of children aged 3 to 8 years: those with ASD and gastrointestinal symptoms, those with ASD without gastrointestinal symptoms, and typically developing children without gastrointestinal issues. Participants in the first two groups will receive a postbiotic dietary supplement called PostbiotiX Comfort® for one month, while the third group will not receive any treatment. PostbiotiX Comfort® contains molecules from Lactobacillus paracasei fermentation that may support intestinal health and barrier integrity without live bacteria risks. Participants will provide stool samples for analysis of their gut bacteria, intestinal permeability, and metabolomic profiles before and after treatment. Researchers will evaluate changes in gastrointestinal symptoms, behavioral regulation, sleep, sensory profile, and the relationship between gut profiles and clinical outcomes over a 24-month period. The study includes assessments by neurologists and neuropsychologists, and all participants will be monitored for safety and treatment effects throughout the study.
CONDITIONS
Brief Title
Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders
Who Can Participate
Age: 3Years - 8Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 8 years
- Diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5 criteria for Groups 1 and 2
- Clinical neurological and neuropsychological evaluation supporting ASD diagnosis
- Assessment of psychomotor or intellectual development
- For Group 1: presence of gastrointestinal symptoms with a score of at least 2 on GI Severity Index items 1-6
- Signed informed consent for microbiota analysis and PostbiotiX Comfort® treatment (Groups 1 and 2)
- Typically developing children aged 3 to 8 years without gastrointestinal symptoms for Group 3
- Signed informed consent for microbiota analysis (Group 3)
You will not qualify if you...
- Syndromic ASD or defined genetic diseases (Groups 1 and 2)
- Significant health problems needing surgery or continuous medical treatment (Groups 1 and 2)
- Severe gastrointestinal problems requiring immediate life-threatening treatment (Groups 1, 2, and 3)
- Severely underweight or malnourished children (Groups 1 and 2)
- Use of antibiotics, probiotics, or prebiotics within 1 month prior to enrollment (Groups 1 and 2)
- Presence of gastrointestinal symptoms such as chronic irregular bowel movements, encopresis, recurrent bloating, gastroesophageal reflux, vomiting, or food aversion in Group 3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 1 month
Participants receive a postbiotic dietary supplement called PostbiotiX Comfort® for 1 month to evaluate its effects on gastrointestinal and behavioral symptoms.
Trial Site Locations
Total: 2 locations
1
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, MI, Italy, 20133
Actively Recruiting
2
IRCCS Humanitas Reasearch Hospital (ICH) Laboratory of Microbiota and Mucosal Immunology
Milan, Italy
Actively Recruiting
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Research Team
S
Stefano D'Arrigo, MD
S
Sara Bulgheroni
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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