RecruitingPhase 1Phase 2NCT06290258

Fecal Microbiota Transplantation for Patients With 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.

Sponsor

Chang Gung Memorial Hospital

Enrollment

60 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy Gastrointestinal Diseases Autism Spectrum Disorder

Summary

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. Early intervention at school-age may even benefit development, improve cognition and prognosis.

Eligibility

Min Age: 7 YearsMax Age: 30 Years

Inclusion Criteria4

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 Criteria10

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.

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Interventions

PROCEDUREFecal microbiota transplantation

Fecal microbiota transplantation has been applied to patients with autism spectrum disorder in recent years. Fecal microbiota of healthy donors can be transplanted to patients through colonoscopy. Before donation, donors were comprehensively screened to rule out gastrointestinal symptoms and infections. Patients will receive colon preparation before transplantation. After the intervention, patients will have to stay in bed and be monitored for 24 hours to assure safety.