Fecal microbiota transplantation for autism spectrum disorder

Fecal Microbiota Transplantation for Gastrointestinal, Autistic, Emotion, and Behavior Symptoms of Patients With Autism Spectrum Disorder and Gastrointestinal Problems: a Preliminary Study.

This study is testing whether a treatment that involves transplanting healthy gut bacteria can help improve gut and autism symptoms in young people with autism spectrum disorder.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 7 Years to 30 Years
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (other)
• Locations: 1 site (Taoyuan City)
• Trial ID: NCT06290258 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children and young adults aged 7-30 diagnosed with autism spectrum disorder and experiencing gastrointestinal problems.

Not a fit: Patients with severe physical or mental illnesses, or those requiring certain medications that interfere with the study, may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve gastrointestinal and behavioral symptoms in children with autism spectrum disorder.

How similar studies have performed: While studies on fecal microbiota transplantation for autism are limited, the approach has shown promise in other gastrointestinal and neurological conditions.

Eligibility criteria

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 this trial is running

Taoyuan City

• Wei-Chih Chin — Taoyuan City, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Wei-Chih Chin — Chang Gung Medical Foundation
• Study coordinator: Wei-Chih Chin

Conditions: Autism Spectrum Disorder, Gastrointestinal Diseases, Healthy, Fecal Microbiota Transplantation, gastrointestinal problems, cytokines, cognitive function