RecruitingPhase 1NCT06030752

WMT for Autism Spectrum Disorder (ASD)

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


Sponsor

The Second Hospital of Nanjing Medical University

Enrollment

80 participants

Start Date

Sep 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 3 YearsMax Age: 17 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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.

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Interventions

DRUGWashed Microbiota Transplantation

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


Locations(2)

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

SIR RUN RUN hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06030752


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