Autism Spectrum Disorder Trial, Recruiting NCT06514573 Sponsor: Istituto Superiore di Sanità Condition: Autism Spectrum Disorder
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Autism Spectrum Disorder Trial, Recruiting

NCT06514573
Recruiting Not Applicable

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 who are between 3 and 6 years old
  • Children of any sex
  • Children who have been diagnosed with Autism Spectrum Disorder (ASD) and also have ongoing digestive/gut problems, based on a specific symptom score (called the 6-item Gastrointestinal Severity Index) above 7, lasting more than 3 months

Who may not be able to join:

  • Children who are older than 6 years
  • Children whose gut/digestive condition has not been clearly diagnosed
  • Children whose gut/digestive symptoms have been present for less than 3 months
  • Children who have another ongoing health condition at the same time, such as food reactions, metabolic disorders, or infections
  • Children who have physical abnormalities or long-term diseases of the digestive or urinary systems
  • Children who have a condition affecting their immune system
  • Children who have diabetes
  • Children who have a neurological, heart, or autoimmune disease
  • Children who have obesity
  • Children who are malnourished
  • Children who have used antibiotics or pre-, pro-, or synbiotic supplements in the 6 months before joining the trial
  • Children who have taken part in another clinical trial in 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 22 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.

Contact this trial

Principal Investigator: Maria Luisa Scattoni, Ph.D., Istituto Superiore di Sanità

Phone: +39 0649903104

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

Status
Recruiting
Phase
Not Applicable
Sponsor
Istituto Superiore di Sanità
Registry
ClinicalTrials.gov
Start date
1 May 2025
Est. completion
1 July 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Gastrointestinal symptom 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: 22 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