Phase 3 Autism Spectrum Disorder Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For Groups 1 and 2 (children with autism and gut symptoms):
- The child has been diagnosed with autism spectrum disorder (ASD) based on recognised medical guidelines (DSM-5)
- The child has been assessed by a specialist children's neurologist and neuropsychologist using standard autism assessment tools
- The child has had their developmental or intellectual level assessed using recognised standardised tests
- In the past three months, the child has experienced gut-related symptoms such as constipation, diarrhoea, unusual stools, gas, stomach pain, unexplained daytime irritability, night waking, or stomach tenderness — and scored at least 2 on at least one gut symptom on a specific questionnaire (confirm with trial site)
- A parent or guardian has signed a consent form agreeing to gut microbiome and metabolite testing and to the child taking a supplement called PostbiotiX Comfort ®
For Group 3 (typically developing children without gut symptoms):
- The child is a boy or girl aged between 3 and 8 years old with typical development and no gut symptoms
- A parent or guardian has signed a consent form agreeing to gut microbiome and metabolite testing
Who may not be able to join:
For Groups 1 and 2:
- Children whose autism is linked to a known genetic condition or syndrome
- Children who have serious health problems that require surgery or ongoing medical treatment
- Children with severe gut problems that need urgent or emergency treatment
- Children who are severely underweight or malnourished
- Children who have taken antibiotics or probiotic/prebiotic supplements within the month before joining the trial
For Group 3:
- Children who have gut problems needing urgent or emergency treatment, or who have ongoing gut symptoms such as chronic constipation or diarrhoea, bowel accidents, recurring bloating or stomach pain, acid reflux, vomiting, or strong food aversions
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Stefano D'Arrigo, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta
Phone: + 39 02.2394
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Modulation of Gastrointestinal Symptoms in ASD with Postbiotic Supplement
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.