WMT for Autism Spectrum Disorder (ASD)

September 7, 2023 updated by: The Second Hospital of Nanjing Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Autism Behavior Checklist (ABC) in ASD children
Time Frame: 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.
baseline, 4 weeks , 8 weeks , 3 month, 6 months post transplantation
Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children
Time Frame: 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.
baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.
Time Frame: 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.
Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.
Parental Global Impressions-Revised
Time Frame: 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.
baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Collaborators

SIR RUN RUN hospital of Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMT-ASD-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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