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Effect of faecal microbiota transplant on the expression of autism spectrum disorder core symptoms in children – open-label phase II clinical trial (FMT-PAS)
EU CTIS ID: 2025-524673-16-00
What this study is testing
The primary objective of the trial is to describe the effect of faecal microbiota transplant (FMT) on autism spectrum disorder core symptoms.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 3–12 years
- Diagnosis of ASD confirmed by a clinical psychologist or psychiatrist
- Previous ADOS-2 examination result in the ASD range
- Only minimum verbal ability (i.e. corresponding to ADOS-2, Module 1)
- Informed consent of the parent (legal representative) and willingness to follow all planned study visits and instructions, especially for bowel preparation
You likely can't join if
- Congenital GIT defect or primary GIT disease, incl. medically confirmed coeliac disease (gluten enteropathy)
- Newly initiated or recently changed formal behavioural, cognitive or cognitive-behavioural therapy (less than 30 days before enrolment)
- Early reaction to food in the patient’s medical history
- Expected inability to undergo bowel preparation (e.g. child’s inability to use liquid medication declared by parent)
- Contraindication for common sedative medication, or serious complications of sedation in the patient’s medical history
- Use of systemic immunosuppressants at present or in the last 3 months, or present medically confirmed immunocompromised status
See the full eligibility criteria
- Age 3–12 years
- Diagnosis of ASD confirmed by a clinical psychologist or psychiatrist
- Previous ADOS-2 examination result in the ASD range
- Only minimum verbal ability (i.e. corresponding to ADOS-2, Module 1)
- Informed consent of the parent (legal representative) and willingness to follow all planned study visits and instructions, especially for bowel preparation
- Congenital GIT defect or primary GIT disease, incl. medically confirmed coeliac disease (gluten enteropathy)
- Newly initiated or recently changed formal behavioural, cognitive or cognitive-behavioural therapy (less than 30 days before enrolment)
- Early reaction to food in the patient’s medical history
- Expected inability to undergo bowel preparation (e.g. child’s inability to use liquid medication declared by parent)
- Contraindication for common sedative medication, or serious complications of sedation in the patient’s medical history
- Use of systemic immunosuppressants at present or in the last 3 months, or present medically confirmed immunocompromised status
- Use of antiplatelet drugs, anticoagulants, or systemic antibiotics at present or in the last 3 months
- Use of probiotics, prebiotics, or postbiotics at present or in the last 3 months
- Severe co-morbid conditions (e.g. psychosis, epilepsy uncontrolled by medication, presence of severe visual or hearing impairment) that may interact with study procedures (at discretion of the investigator)
- Newly initiated or recently changed pharmacotherapy (less than 30 days before enrolment)
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.