Gut barrier and gut microbes in children with autism
Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders: Evaluation of Efficacy of Postbiotic-based Nutraceutical Treatment
This trial will test whether a one-month course of postbiotic supplements can improve gut symptoms and behavior in children with autism aged 3–8.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 2 sites (Milan, MI and 1 other locations) |
| Trial ID | NCT07450443 on ClinicalTrials.gov |
What this trial studies
This non-pharmacological Phase 2/3 interventional trial enrolls children aged 3–8 with DSM-5 autism and collects baseline clinical, behavioral, and gastrointestinal data. Stool samples will be collected and analyzed for metagenomic and metabolomic profiles and markers of intestinal permeability at Humanitas before and after a one-month course of a postbiotic-based dietary supplement (PostbiotiX Comfort®) or control. Investigators will compare changes in gastrointestinal symptoms, behavioral measures, and microbial/metabolite profiles to see if the supplement alters gut biology and correlates with clinical improvements. The trial is conducted collaboratively by Fondazione IRCCS Istituto Neurologico Carlo Besta and Istituto Clinico Humanitas with sample collection and follow-up in Milan.
Who should consider this trial
Good fit: Children aged 3–8 with a DSM‑5 diagnosis of ASD confirmed by standardized instruments (e.g., ADOS‑2/ADI‑R) and developmental testing who have at least one significant GI symptom (GI Severity Index item score ≥2) are eligible.
Not a fit: Children without notable gastrointestinal symptoms, those outside the 3–8 age range, or those with other medical conditions affecting the gut or neurodevelopment may be unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, the supplement could reduce bowel problems and improve behavioral regulation in some children with ASD, offering a non-drug management option.
How similar studies have performed: Human data on postbiotics in ASD are scarce and mostly absent, with supportive evidence limited to mouse models while other microbiome interventions in humans (probiotics, FMT) have produced mixed and preliminary results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan, MI and 1 other locations
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Mi, Italy (Recruiting)
- IRCCS Humanitas Reasearch Hospital (ICH) Laboratory of Microbiota and Mucosal Immunology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano D'Arrigo, MD — Fondazione IRCCS Istituto Neurologico Carlo Besta
- Study coordinator: Stefano D'Arrigo, MD
- Email: stefano.darrigo@istituto-besta.it
- Phone: + 39 02.2394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.