WMT for Autism Spectrum Disorder (ASD)

Sponsor

The Second Hospital of Nanjing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06030752

Collaborator

SIR RUN RUN hospital of Nanjing Medical University (Other)

Enrollment

Arm

6.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Drug: Washed Microbiota Transplantation	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Washed Microbiota Transplantation (WMT) for Autism Spectrum Disorder (ASD)

Anticipated Study Start Date :

Sep 20, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WMT WMT with microbiota suspension Participants undergo repeated FMT with ~50ml microbiota suspension.	Drug: Washed Microbiota Transplantation The prepared microbiota suspension was infused into the participates' lower gut. Other Names: Fecal Microbiota Transplantation

Arm

Intervention/Treatment

Experimental: WMT

WMT with microbiota suspension Participants undergo repeated FMT with ~50ml microbiota suspension.

Drug: Washed Microbiota Transplantation

The prepared microbiota suspension was infused into the participates' lower gut.

Other Names:

Fecal Microbiota Transplantation

Outcome Measures

Primary Outcome Measures

Changes in the Autism Behavior Checklist (ABC) in ASD children [baseline, 4 weeks , 8 weeks , 3 month, 6 months post transplantation]
ABC is a scale used for nonadaptive behaviors created to screen and indicate the probability of a diagnosis of autism. The questionnaire including 57 items related to five areas: sensorial, relational, use of body and objects, and social skills. Scale score> 67 strongly suggests the presence of autism.
Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children [baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation]
ASD symptoms will be assessed using the Chinese version of the Autism Treatment Evaluation Checklist (ATEC), which comprise four subscales to measure child speech/language/communication, sociability, sensory/cognitive awareness, and health/physical/behavior. The scale has 77 items that are scored by parents. The health/physical/behavior subscale is rated using a 0 (not a problem)-to-3 (serious problem) point scale, whereas the other three subscales are rated using a 0 (not true)-to-2 (very true) point scale. Higher scores represent more ASD symptoms.

Secondary Outcome Measures

Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome. [Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.]
The composition of the gut microbe was evaluated by sequencing faecal metagenome. We evaluate the differences in the structure of the flora and its metabolism between the two at the phylum, genus and species levels of the intestinal flora and control children, and to develop a model for predicting the structure of the flora.
Parental Global Impressions-Revised [baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation]
The PGI-R is a rating of change of 18 autism symptoms compared to baseline, with each symptom rated on a Likert scale from -3 (much worse) to zero (no change) to +3 (much better). We report the average change of the 18 symptoms, so the possible range is from -3 to +3.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and ADOS-2 diagnostic criteria.
Age 3-14years.

Exclusion Criteria:

ASD children with severe gastrointestinal symptoms or organic disease requiring immediate surgery or treatment.
ASD children who have received antibiotics within 3 months, or are receiving immunosuppressive agents and biologics.
ASD children with underlying diseases, such as severe anemia, malnutrition, autoimmune diseases (autoimmune thyroiditis, type I diabetes, etc.), allergic diseases (asthma, severe eczema, etc.), central nervous system diseases, metabolic syndrome, etc.
ASD children with other organic dysfunctions, such as cerebral palsy, congenital genetic diseases, etc.; history of other psychiatric-behavioral disorders, genetic-metabolic diseases and other major physical diseases; other physical diseases, such as hearing impairment, vocal disorders, blindness, etc.