Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07450443 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders

Study acronym: DSA/GVB
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07450443
Lead Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators: Istituto Clinico Humanitas
Conditions
(from sponsor)		 Autism, Autism Disorder, Autism Spectrum Disorder (ASD)
Related terms Autism Spectrum Disorder, Autistic Disorder
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov