Actively Recruiting
Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-03-04
90
Participants Needed
2
Research Sites
245 weeks
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
Recent research links gut microbiota alterations to Autism Spectrum Disorders (ASD), a neurobiological condition with multifactorial bases. In some ASD patients, altered gut flora and increased intestinal permeability are observed, influencing the central nervous system's development and function. Chronic gastrointestinal (GI) symptoms are commonly associated with ASD and correlate with its severity. This non-pharmacological interventional clinical study aims to investigate the role of gut microbiota on ASD and the effectiveness of postbiotic-based dietary supplements in children aged 3-8 years old. Gastrointestinal symptoms, behavioral profile and analysis of intestinal metagenomic and metabolomic profiles will be assessed before and after one-month treatment. The results of the study could enhance understanding of non-pharmacological therapeutic approaches in ASD and improve clinical management strategies and the behavioural functioning for children with ASD.
CONDITIONS
Official Title
Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 8 years with a diagnosis of ASD based on DSM-5 criteria
- Clinical neurological and neuropsychological evaluation supporting ASD diagnosis with standardized instruments
- Assessment of psychomotor or intellectual development using recognized scales
- Presence of at least one gastrointestinal symptom (such as constipation, diarrhea, abnormal stool consistency, flatulence, abdominal pain, irritability, or abdominal tenderness) with a minimum severity score
- Signed informed consent for microbiota analysis and postbiotic supplement treatment
- Typically developing children aged 3 to 8 years without gastrointestinal symptoms for control group
- Signed informed consent for microbiota analysis for control group
You will not qualify if you...
- Children with syndromic ASD or known genetic diseases
- Children with serious health problems requiring surgery or continuous medical treatment
- Severe gastrointestinal problems needing immediate life-threatening treatment
- Severely underweight or malnourished children
- Use of antibiotics, probiotics, or prebiotics within 1 month before enrollment
- Participants with gastrointestinal symptoms requiring immediate treatment or chronic GI issues such as constipation, diarrhea, encopresis, bloating, reflux, vomiting, or food aversion in control group
AI-Screening
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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
Research Team
S
Stefano D'Arrigo, MD
CONTACT
S
Sara Bulgheroni
CONTACT
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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