Actively Recruiting

Phase 1
Age: 3Years - 17Years
All Genders
NCT06030752

WMT for Autism Spectrum Disorder (ASD)

Led by The Second Hospital of Nanjing Medical University · Updated on 2025-09-05

80

Participants Needed

2

Research Sites

188 weeks

Total Duration

On this page

Sponsors

T

The Second Hospital of Nanjing Medical University

Lead Sponsor

N

Nanjing Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

WMT for Autism Spectrum Disorder (ASD)

Who Can Participate

Age: 3Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents diagnosed with ADHD or both ADHD and Autism Spectrum Disorder according to DSM-5
  • Age between 3 and 17 years
  • Stable treatments for at least 1 month before starting Washed Microbiota Transplantation
Not Eligible

You will not qualify if you...

  • Guardian unable to understand questionnaires or provide informed consent
  • Diagnosis of single-gene disorder, major brain malformations, or gastrointestinal diseases such as ulcerative colitis, Crohn's disease, or eosinophilic esophagitis
  • Severe comorbid conditions including cardiopulmonary failure, severe liver or kidney disease, severe infection, or tumors
  • Presence of other life-threatening disorders requiring emergency treatment
  • Inability to tolerate colonoscopy or anesthesia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

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

Nanjing, Jiangsu, China

Actively Recruiting

2

SIR RUN RUN hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Actively Recruiting

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Research Team

F

Faming Zhang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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