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New treatment option for Autism Spectrum Disorder
Official title Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.
ClinicalTrials.gov ID: NCT06290258
What this study is testing
- What it's testing
- This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 30. Healthy volunteers may be eligible.
You may be able to join if
- Diagnosed by a child psychiatrist in line with DSM-5 Autism Spectrum Disorder
- Combined with gastrointestinal problems, any Gastrointestinal Symptoms Rating Scale score≧3.
- Age is between 7-30.
- Participants who are willing to participate in the study and sign the informed consent.
You likely can't join if
- Cases where clinical assessment cannot cooperate with fecal microbiota transplantation and examination.
- Cases requiring antibiotics within 3 months before or after acceptance because of their physiological condition.
- Cases requiring long-term use of proton pump inhibitors due to their physiological conditions.
- Severe physical diseases, such as acute gastrointestinal diseases, severe malnutrition or underweight, immunodeficiency diseases, severe allergies or...
- Severe mental illness, such as schizophrenia, bipolar disorder, etc.
- Those who used probiotics one month before the case may affect the intestinal flora.
See the full eligibility criteria
- Diagnosed by a child psychiatrist in line with DSM-5 Autism Spectrum Disorder
- Combined with gastrointestinal problems, any Gastrointestinal Symptoms Rating Scale score≧3.
- Age is between 7-30.
- Participants who are willing to participate in the study and sign the informed consent.
- Cases where clinical assessment cannot cooperate with fecal microbiota transplantation and examination.
- Cases requiring antibiotics within 3 months before or after acceptance because of their physiological condition.
- Cases requiring long-term use of proton pump inhibitors due to their physiological conditions.
- Severe physical diseases, such as acute gastrointestinal diseases, severe malnutrition or underweight, immunodeficiency diseases, severe allergies or autoimmune diseases, brain injuries or severe organic brain diseases...
- Severe mental illness, such as schizophrenia, bipolar disorder, etc.
- Those who used probiotics one month before the case may affect the intestinal flora.
- Pregnancy.
- Cases that cannot understand the content of this research.
- Participants who are unwilling to participate in the study or refuse to sign the informed consent.
- Participants who are not suitable to include in this study, evaluate by PI or Co-PI.
The study team makes the final eligibility decision.
Where it's taking place
- Taoyuan City, Taiwan
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, 7 years to 30 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taoyuan City, Taiwan. 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.