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RECRUITING

NCT07450443

PHASE2/PHASE3

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

Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

View on ClinicalTrials.gov

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.

Official title: Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders: Evaluation of Efficacy of Postbiotic-based Nutraceutical Treatment

Key Details

Gender

All

Age Range

3 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-03-21

Completion Date

2027-12

Last Updated

2026-03-04

Healthy Volunteers

Yes

Conditions

Autism Autism Disorder Autism Spectrum Disorder (ASD)

Interventions

DIETARY_SUPPLEMENT

PostbiotiX Comfort®

Treatment with a postbiotic dietary supplement, PostbiotiX Comfort®, administered for 1 month in participants from Group 1 and Group 2.

OTHER

Control

Participants in Group 3 do not receive any treatment.

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 significant health problems requiring surgical treatment or continuous medical; treatment; * Severe gastrointestinal problems requiring immediate (life-threatening) treatment; * Severely underweight/malnourished children; * Use of medications that may affect biomarkers assessed, for example: antibiotics and/or pre-, probiotics within 1 month prior to enrollment. Group 3 exclusion criteria \- Participants with gastrointestinal problems requiring immediate (life-threatening) treatment, or with gastrointestinal symptoms such as chronic irregular bowel movements (constipation, diarrhea), encopresis, recurrent abdominal bloating and pain, gastroesophageal reflux and vomiting, or food aversion.

Locations (2)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, MI, Italy

IRCCS Humanitas Reasearch Hospital (ICH) Laboratory of Microbiota and Mucosal Immunology

Milan, Italy