RecruitingPhase 2/3

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

Italy90 participantsStarted 2023-03-21

Plain-language summary

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.

Who can participate

Age range3 Years – 8 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Group 1 and 2: Inclusion criteria * 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. * Signed informed consent for analysis of intestinal microbiota and metabolome and administration of nutraceutical therapy with PostbiotiX Comfort ®. Group 3 Inclusion criteria * Males or females aged between 3 and 8 years whit typical development and absence of gastrointestinal symtomps * Signed informed consent for analysis of intestinal microbiota and metabolome Exclusion Criteria: Group 1 and 2 * Exclusion Criteria * Children with syndromic ASD or defined genetic diseases; * Subjects with s…

What they're measuring

Modulation of Gastrointestinal Symptoms in ASD with Postbiotic Supplement

Timeframe: 24 months

Trial details

NCT IDNCT07450443

SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Stefano D'Arrigo, MD

+ 39 02.2394 stefano.darrigo@istituto-besta.it