Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders
Recruiting
Phase 2
Phase 3
Interventional Study
Autism
Autism Disorder
Autism Spectrum Disorder (ASD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 3 – 8
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Other
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About This Trial
Recent research links gut microbiota alterations to Autism Spectrum Disorders (ASD), a neurobiological condition with multifactorial bases. In some ASD patients, altered gut flora and increased intestinal permeability are observed, influencing the central nervous system's development and function. Chronic gastrointestinal (GI) symptoms are commonly associated with ASD and correlate with its severi…
Trial Locations
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Eligibility 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…
Contacts