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New treatment option for Autism
Official title Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders
ClinicalTrials.gov ID: NCT07450443
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 8. Healthy volunteers may be eligible.
You may be able to join if
- Group 1 and 2:
- 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...
- 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...
You likely can't join if
- Group 1 and 2
- Exclusion Criteria
- Children with syndromic ASD or defined genetic diseases;
- people with significant health problems requiring surgical treatment or continuous medical; treatment;
- Severe gastrointestinal problems requiring immediate (life-threatening) treatment;
- Severely underweight/malnourished children;
See the full eligibility criteria
- Group 1 and 2:
- 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...
- 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...
- Signed informed consent for analysis of intestinal microbiota and metabolome and administration of nutraceutical therapy with PostbiotiX Comfort ®. Group 3 Males or females aged between 3 and 8 years whit typical...
- Signed informed consent for analysis of intestinal microbiota and metabolome
- Group 1 and 2
- Exclusion Criteria
- Children with syndromic ASD or defined genetic diseases;
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Milan, MI, Italy
- Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 8 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, MI, Italy; Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.