Gut barrier and gut microbes in children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Museum visits to support social and emotional well‑being in autistic adults

  This study tests whether visiting the National Taiwan Museum can help improve social participation and well-being for autistic adults aged 18–50.

  Recruiting National Taiwan University Hospital · Taipei · NCT07768332

• AdiaVita and glutathione for autism in kids and teens

  This study tests whether adding AdiaVita (cord-blood stem cells and exosomes) to glutathione helps improve ASD symptoms in children and other participants compared with glutathione alone.

  Recruiting at 2 sites Phase 1 Greater Atlanta Integrative Pediatrics · Roswell, Georgia and 1 other locations · NCT07622316

• Online test of BlinkLab Dx1 for autism in kids aged 2–11

  This study tests whether the BlinkLab Dx1 smartphone app can help identify autism in children aged 2 to 11 by comparing app-based measurements with prior clinical diagnoses.

  Recruiting Blinklab Limited · Princeton, New Jersey · NCT07590973

• CRUSH curriculum for romance and sexual health for autistic young adults

  This project will try the CRUSH program—a group course plus one-to-one coaching—to teach sexual health and dating skills to autistic adults ages 18 to 30.

  Recruiting Boston Children's Hospital · Brookline, Massachusetts · NCT07406100

• Virtual reality to improve emotion understanding in children with autism

  This project will test whether an Oculus virtual-reality program helps children with autism better recognize and understand emotions compared with a traditional intervention.

  Recruiting Istituto per la Ricerca e l'Innovazione Biomedica · Messina, Italy · NCT07367256

• Do AdiaVita stem cells plus glutathione help kids with autism more than glutathione alone?

  This 12-month study tests whether adding AdiaVita stem cells and exosomes to glutathione helps children aged 3–12 with autism more than glutathione alone.

  Recruiting at 2 sites Phase 1 Adia Med of Winter Park LLC · Winter Park, Florida and 1 other locations · NCT07304440

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.