Autism Spectrum Disorder Trial, Recruiting (NCT07345585)

Autism Spectrum Disorder Trial, Recruiting NCT07345585 Sponsor: Federico II University Condition: Autism Spectrum Disorder

Printed from Voxsanity (voxsanity.com.au) — NCT07345585 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Autism Spectrum Disorder

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:

Children between the ages of 4 and 12 years (inclusive)
Children of any sex
Children who have a confirmed diagnosis of both autism spectrum disorder (ASD) and functional gut/digestive problems (FGIDs), with symptom severity reaching a certain threshold score (GSI of 7 or higher) that has been present for at least 3 months

Who may not be able to join:

Children younger than 4 or older than 12 years
Children whose diagnosis of autism spectrum disorder and/or functional digestive problems has not been clearly confirmed
Children whose digestive problems have been present for less than 3 months
Children who also have certain other ongoing health conditions, such as food allergies or intolerances, genetic or metabolic disorders, structural problems with the digestive, breathing, or urinary systems, neurological conditions, immune system disorders, diabetes, heart conditions, autoimmune diseases, chronic infections, chronic digestive or urinary tract diseases, obesity, cancer, or malnutrition
Children who have taken antibiotics or probiotic, prebiotic, or synbiotic supplements in the 6 months before enrolling in the trial
Children who have taken part in another clinical trial within the past 12 months

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07345585

Sponsor: Federico II University

Phase: Not Applicable

Status: Recruiting

Condition: Autism Spectrum Disorder

More information: https://clinicaltrials.gov/study/NCT07345585

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Children between the ages of 4 and 12 years (inclusive)
Children of any sex
Children who have a confirmed diagnosis of both autism spectrum disorder (ASD) and functional gut/digestive problems (FGIDs), with symptom severity reaching a certain threshold score (GSI of 7 or higher) that has been present for at least 3 months

Who may not be able to join:

Children younger than 4 or older than 12 years
Children whose diagnosis of autism spectrum disorder and/or functional digestive problems has not been clearly confirmed
Children whose digestive problems have been present for less than 3 months
Children who also have certain other ongoing health conditions, such as food allergies or intolerances, genetic or metabolic disorders, structural problems with the digestive, breathing, or urinary systems, neurological conditions, immune system disorders, diabetes, heart conditions, autoimmune diseases, chronic infections, chronic digestive or urinary tract diseases, obesity, cancer, or malnutrition
Children who have taken antibiotics or probiotic, prebiotic, or synbiotic supplements in the 6 months before enrolling in the trial
Children who have taken part in another clinical trial within the past 12 months

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Federico II University

Registry

ClinicalTrials.gov

Start date

1 January 2023

Est. completion

1 March 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Functional gastrointestinal disorders (FGIDs) severity

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov