Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age3-8
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of ASD according to DSM-5 diagnostic criteria;
Clinical neurological evaluation by child neurologist and neuropsychologist with administration of standardized instruments such as Autism Diagnostic Observation Schedule-2 (ADOS-2) and/or Autism Diagnostic Interview-Revised (ADI-R) to support diagnosis;
Assessment of psychomotor or intellectual development (Griffiths Scales, Wechsler Scales, Leiter Scale)
Assessment of the following symptoms in the past three months: constipation, diarrhea, abnormal stool consistency, abnormal stool smell, flatulence, abdominal pain, unexplained daytime irritability, and nighttime awakening, and abdominal tenderness. The degree of gastrointestinal disturbances will be quantified before recruitment using an Italian version of the GI Severity Index. A score of at least 2 in a single item of gastrointestinal symptoms (item 1-6) was required for entry into the symptomatic group.
Disqualifiers
Exclusion Criteria
Children with syndromic ASD or defined genetic diseases;
Subjects with significant health problems requiring surgical treatment or continuous medical; treatment;
Severe gastrointestinal problems requiring immediate (life-threatening) treatment;
Trial design
Treatments tested in this trial
- PostbiotiX Comfort®
- Control
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead sponsor
Istituto Clinico Humanitas
Collaborator
Source ClinicalTrials.gov