Fecal microbiota transplantation for autism spectrum disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of fecal microbiota transplantation (FMT) in improving gastrointestinal and autistic symptoms in patients with autism spectrum disorder (ASD). It focuses on the relationship between the brain-gut axis, cytokines, and ASD, aiming to enhance intestinal microbiota composition and regulate immune responses. The study will recruit 45 patients aged 6-30 with ASD and gastrointestinal issues, who will undergo FMT and receive regular follow-ups for one year to assess symptom changes.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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, will affect the evaluation of treatment results.
* 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.

Where it's running

• Wei-Chih Chin
  Taoyuan City, Taiwan Recruiting

Study contacts

• Principal investigator: Wei-Chih Chin — Chang Gung Medical Foundation
• Study coordinator: Wei-Chih Chin
• Email: auaug0327@cgmh.org.tw
• Phone: +886 3 3281200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sensory Integration and Deep Pressure Therapy for Motor Coordination in Children with ASD

  This study tests whether combining Sensory Integration Therapy with Deep Pressure Therapy can improve motor coordination and reduce repetitive behaviors in children aged 4–10 with autism.

  Recruiting Riphah International University · Rawalpindi, Punjab Province · NCT07911904

• Pupillometer screen to help identify autism in kids aged 2–4 during routine visits

  A handheld pupillometer test is being tried to see if it can help identify autism in young children during regular pediatric visits.

  Recruiting at 4 sites Schweitzer Engineering Laboratories · Lewiston, Idaho and 3 other locations · NCT07903675

• Leopard: using multi-omics to boost genetic diagnosis for neurodevelopmental disorders

  This study tests a multi-omics approach to find genetic explanations for neurodevelopmental disorders in people with moderate-to-severe intellectual disability.

  Recruiting Istituto Giannina Gaslini · Genova · NCT07884227

• Heart Rate Variability Biofeedback for Anxiety in Autistic Youth

  This study tests a wearable heart rate variability biofeedback tool to see if it helps reduce anxiety in autistic teens.

  Recruiting Phase 2 Massachusetts General Hospital · Lexington, Massachusetts · NCT07812233

• Structured Sensory-Based Occupational Therapy for Children with Autism

  This study tests a 12-week, 40-minute sensory-based occupational therapy program twice a week to see if it improves daily skills, sensory processing, movement, and eating in children aged 3-9 with autism.

  Recruiting Medipol University · Istanbul, Beykoz · NCT07789704

• Exergaming and Aerobic Exercise for Kids with Autism

  This study tests whether adding exergames or aerobic exercise to a standard program helps improve sleep, movement skills, thinking skills, and brain activity in children with autism.

  Recruiting National Taiwan University Hospital · Taipei · NCT07789457

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.