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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Fecal microbiota transplantation
Procedure/SurgeryFecal 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Fecal microbiota transplantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes of gastrointestinal symptoms of patients with ASD after FMT
the Gastrointestinal Symptom Rating Scale, score 15-105, higher scores mean more severe symptom
Time frame
baseline and the 1-year follow-up2
Changes of autistic symptoms of patients with ASD after FMT
the Social Responsiveness Scale, score 0-195, higher scores mean more severe symptom
Time frame
baseline and the 1-year follow-upSecondary outcomes
1
Changes of the diversity of intestinal microbiota of patients with ASD after FMT
microbial DNA was extracted from feces by Reagent Kit v3, and the diversity indices were calculated by using the vegan package in R version 3.2.3. higher indices suggest higher microbial diversity
Time frame
baseline and the 1 year follow-up2
Changes of cytokine levels of patients with ASD after FMT
cytokine levels
Time frame
baseline and the 1 year follow-up3
Changes of repetitive behavior symptoms of patients with ASD after FMT
the Repetitive Behavior Scale-Revised data, higher score suggest more repetitive behavior
Time frame
baseline and the 1 year follow-up4
Changes of autistic behavior symptoms of patients with ASD after FMT
the Aberrant Behavior Checklist data, higher score suggest more autistic behavior
Time frame
baseline and the 1 year follow-upOther outcomes
1
Changes of objective sleep of patients with ASD after FMT by actigraphy recording
Participants wear actigraphy for 7-10 days to record their activities and light exposure, which can be calculated to represent their sleep patterns. Sleep parameters including (total sleep time: minutes, sleep efficiency: percentage, total time in bed: minutes, sleep onset latency: minutes, wakefulness after sleep onset: minutes, the sum of wake duration overnight: minutes, total number of awakenings: times, sleep onset time and wake time: hours and minutes) will be obtained and analyzed.
Time frame
baseline and the 1 year follow-up2
Changes of subjective sleep of patients with ASD after FMT
the Children's Sleep Habits Questionnaire data, higher score suggest poorer sleep
Time frame
baseline and the 1 year follow-up3
Changes of intelligence of patients with ASD after FMT
the Wechsler Intelligence Scale data, higher score suggest better intelligence
Time frame
baseline and the 1 year follow-up4
Changes of attention and impulse control of patients with ASD after FMT
the Conners' Continuous Performance Test data, higher score suggest worse attention and impulse control
Time frame
baseline and the 1 year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov