Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

Condition(s) studied

Investigational drug(s) / intervention(s)

Fecal 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.

Study 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

Primary outcome measure(s)

• Changes of gastrointestinal symptoms of patients with ASD after FMT — baseline and the 1-year follow-up
  the Gastrointestinal Symptom Rating Scale, score 15-105, higher scores mean more severe symptom
• Changes of autistic symptoms of patients with ASD after FMT — baseline and the 1-year follow-up
  the Social Responsiveness Scale, score 0-195, higher scores mean more severe symptom

Trial sites (1)

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