An observational study in Autism Spectrum Disorder, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 2 sites in China. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by The Second Hospital of Nanjing Medical University · Observational
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.
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.
Children and adolescents with an established diagnosis of ASD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;.
Exclusion Criteria:
WMT
Drug: Washed Microbiota Transplantation
The prepared microbiota suspension was infused into the participates' lower gut.
Also known as: Fecal Microbiota Transplantation
Changes in the Autism Behavior Checklist (ABC) in ASD children
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.
Time frame: baseline, 1 month , 3 months, 6 months post transplantation
Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children
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.
Time frame: baseline, 1 month,3 months, 6 months post transplantation
Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.
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.
Time frame: Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.
The Sleep Disturbance Scale for Children
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
Time frame: baseline, 1 month, 3 months, 6 months post transplantation
The Gastrointestinal Symptom Rating Scale
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).
Time frame: baseline, 1 month, 3 months, 6 months post transplantation
Clinical Global Impressions-Improvement
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.
Time frame: baseline, 1 months, 3 months, 6 months post transplantation
The Chinese version of Swanson, Nolan, and Pelham-IV (SNAP-IV)
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).
Time frame: At baseline, 1 month, 3 months and 6 months after WMT
Conners' Parent Rating Scale-Revised (CPRS-R)
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.
Time frame: At baseline, 1 month, 3 months and 6 months after WMT
Plan to share: No
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The Second Hospital of Nanjing Medical University