Clinical trial NCT06030752: WMT for Autism Spectrum Disorder (ASD)
Official title: Washed Microbiota Transplantation (WMT) for Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Autism Spectrum Disorder
Keywords: fecal Microbiota Transplantation
Autism spectrum disorder
Gut microbiota
Gut-brain axis
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Medical University
First posted: 2023-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. Intestinal microbial disturbance is common in children with ASD. A great deal of evidence shows that intestinal microbes can influence the brain to play its role through "gut-brain-microbiota axis". We intend to explore the role of Washed Microbiota Transplantation in improving symptoms of children in autism spectrum disorder; To study the potential etiological mechanism of autism spectrum disorder.

Detailed description: Very few literatures reported the clinical use of microbiota or bacteria for Autism Spectrum Disorder. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (WMT). Washed microbiota transplantation (WMT) can significantly reduce FMT-related AEs by removing parasite eggs, fecal particles, and fungi through a series of automated washing procedures. This study aims to evaluate the efficacy and safety of FMT for ASD. Patients received repeated WMT with fecal from healthy donors. Microbiota analysis will also be performed on both the donor and recipient stool sample prior to transplantation, and on the recipient sample at 3 month post transplantation. This study sought to evaluate the efficacy of washed microbiota transplantation (WMT) in children with ASD and explore the role of washed bacteria transplantation in improving ASD symptoms.

Eligibility criteria: Inclusion Criteria:

* Children who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for at least 3 months.
* Age 3-14years.
* Received WMT

Exclusion Criteria:

* their guardian could not understand the questionnaires or provide informed consent.
* diagnosed with a single-gene disorder, major brain malformations, gastrointestinal diseases (ulcerative colitis, Crohn's disease, or eosinophilic esophagitis)
* had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases, severe infection, tumors, etc.
* accompanied with other life-threatening disorders required emergency treatment.
* used antibiotics or probiotics three months before WMT.

Primary outcomes:
measure: Changes in the Autism Behavior Checklist (ABC) in ASD children
timeFrame: baseline, 1 month , 3 months, 6 months post transplantation
measure: Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children
timeFrame: baseline, 1 month,3 months, 6 months post transplantation
Secondary outcomes:
measure: Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.
timeFrame: Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.
measure: Parental Global Impressions-Revised
timeFrame: baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation
measure: The Sleep Disturbance Scale for Children
timeFrame: baseline, 1 month, 3 months, 6 months post transplantation
measure: The Gastrointestinal Symptom Rating Scale
timeFrame: baseline, 1 month, 3 months, 6 months post transplantation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: SIR RUN RUN hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
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