NCT07450443 Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders
| NCT ID | NCT07450443 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Condition | Autism |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-03-21 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2023-03-21 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 severity. This non-pharmacological interventional clinical study aims to investigate the role of gut microbiota on ASD and the effectiveness of postbiotic-based dietary supplements in children aged 3-8 years old. Gastrointestinal symptoms, behavioral profile and analysis of intestinal metagenomic and metabolomic profiles will be assessed before and after one-month treatment. The results of the study could enhance understanding of non-pharmacological therapeutic approaches in ASD and improve clinical management strategies and the behavioural functioning for children with ASD.
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) 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.
Contact & Investigator
Stefano D'Arrigo, MD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Istituto Neurologico Carlo Besta
Frequently Asked Questions
Who can join the NCT07450443 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 8 Years, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07450443 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07450443 currently recruiting?
Yes, NCT07450443 is actively recruiting participants. Contact the research team at stefano.darrigo@istituto-besta.it for enrollment information.
Where is the NCT07450443 trial being conducted?
This trial is being conducted at Milan, Italy, Milan, Italy.
Who is sponsoring the NCT07450443 clinical trial?
NCT07450443 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The principal investigator is Stefano D'Arrigo, MD at Fondazione IRCCS Istituto Neurologico Carlo Besta. The trial plans to enroll 90 participants.