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NCT Number: NCT06030752

WMT for Autism Spectrum Disorder (ASD)

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Washed Microbiota Transplantation

Drug

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

Other names: Fecal Microbiota Transplantation

Primary outcomes

  1. Changes in the Autism Behavior Checklist (ABC) in ASD children

    Time frame: baseline, 1 month , 3 months, 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.

  2. Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children

    Time frame: baseline, 1 month,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.

Secondary outcomes

  1. 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.

  2. The Sleep Disturbance Scale for Children

    Time frame: baseline, 1 month, 3 months, 6 months post transplantation

    The Sleep Disturbance Scale for Children (SDSC) was used to assess sleep quality in children with ASD. It had 26 items, each with a score from 0-4. Higher SDSC scores indicated poorer sleep quality

  3. The Gastrointestinal Symptom Rating Scale

    Time frame: baseline, 1 month, 3 months, 6 months post transplantation

    The Gastrointestinal Symptom Rating Scale (GSRS) was used to assess gastrointestinal symptoms. It was a 7-point Likert scale questionnaire with 15 items. The 15 items can be divided into 5 dimensions: abdominal pain (3 items), reflux (2 items), dyspepsia (4 items), diarrhea (3 items), and constipation (3 items).

  4. Clinical Global Impressions-Improvement

    Time frame: baseline, 1 months, 3 months, 6 months post transplantation

    The Clinical Global Impressions-Improvement (CGI-I) evaluated by experienced clinician was used to assess the symptom changes relative to baseline, rated on a 7-point scale from 1 (very much improved) to 7 (very much worse) [26]. CGI-I = 1 or 2 was considered a clinical response.

  5. The Chinese version of Swanson, Nolan, and Pelham-IV (SNAP-IV)

    Time frame: At baseline, 1 month, 3 months and 6 months after WMT

    It was a 26-item questionnaire that measured three of the ADHD symptoms, inattention (items 1-9), hyperactivity (items 10-18), and oppositional defiant disorder (items 19-26). The 26-item checklist was scored on a 4-point Likert scale ranging between Not At All (0) and Very Much (3).

  6. Conners' Parent Rating Scale-Revised (CPRS-R)

    Time frame: At baseline, 1 month, 3 months and 6 months after WMT

    The CPRS-R was composed of 10 items derived from the Revised Conners Parent Rating Scale. It used a 4-point Likert scale (range: 0-30), with higher scores indicating more severe symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Faming Zhang, PhD

CONTACT

[email protected]

086-25-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Collaborators

  • Nanjing Medical University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2023
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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