WMT for Autism Spectrum Disorder (ASD)

Nanjing Medical University

Status and phase

Enrolling

Phase 1

Conditions

Autism Spectrum Disorder

Treatments

Drug: Washed Microbiota Transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT06030752

WMT-ASD-2023

Details and patient eligibility

About

Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. A significant comorbidity exists between ADHD and ASD: 30%-50% of individuals with ASD exhibit ADHD symptoms, and two-thirds with ADHD show ASD traits. 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 ASD with or without ADHD; To study the potential etiological mechanism of WMT for the neurodevelopmental disorders.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

3 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children and adolescents with an established diagnosis of ADHD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;.
Age 3-17 years.
Received stable treatments for ≥1 month preceding 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.
Unable to tolerate colonoscopy or anesthesia.