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Search / Trial NCT06030752

WMT for Autism Spectrum Disorder (ASD)

Launched by THE SECOND HOSPITAL OF NANJING MEDICAL UNIVERSITY · Sep 7, 2023

Trial Information

Current as of July 04, 2025

Recruiting

Keywords

Fecal Microbiota Transplantation Autism Spectrum Disorder Gut Microbiota Gut Brain Axis

ClinConnect Summary

This clinical trial, titled "WMT for Autism Spectrum Disorder (ASD)," is investigating a treatment called Washed Microbiota Transplantation (WMT) to see if it can help improve symptoms in children with autism. Researchers believe that the bacteria in our intestines may affect how the brain works, and they want to explore how changing these gut microbes could impact children diagnosed with autism. The trial is currently looking for participants aged 3 to 14 who have been diagnosed with autism for at least three months.

To be eligible for the study, children must meet specific criteria, such as having a diagnosis of autism according to accepted guidelines. However, children with certain medical conditions, like severe gastrointestinal diseases or other serious health issues, cannot participate. Families who join the trial can expect to receive the WMT treatment and help researchers learn more about autism and how it might be treated in the future. It's important to note that this is an early-phase trial, meaning it's one of the first steps in testing this new treatment.

Gender

ALL

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 3-17 years.
  • 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.

About The Second Hospital Of Nanjing Medical University

The Second Hospital of Nanjing Medical University is a leading clinical research institution dedicated to advancing healthcare through innovative research and rigorous clinical trials. Affiliated with Nanjing Medical University, the hospital is equipped with state-of-the-art facilities and a multidisciplinary team of experienced professionals. The institution focuses on a wide range of medical specialties, aiming to enhance patient care and treatment outcomes by evaluating new therapies and interventions. Committed to ethical research practices and patient safety, the Second Hospital of Nanjing Medical University plays a pivotal role in contributing to the scientific community and improving public health.

Locations

Nanjing, Jiangsu, China

Nanjing, Jiangsu, China

Patients applied

0 patients applied

Trial Officials

Faming Zhang, PhD

Principal Investigator

The Second Hospital of Nanjing Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported