Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age7-30
SponsorChang Gung Memorial Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Fecal microbiota transplantation
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov