Autism Spectrum Disorder
Conditions
Keywords
fecal Microbiota Transplantation, Autism spectrum disorder, Gut microbiota, Gut-brain axis
Brief summary
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.
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.
Interventions
The prepared microbiota suspension was infused into the participates' lower gut.
Sponsors
Nanjing Medical University
The Second Hospital of Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Autism Behavior Checklist (ABC) in ASD children | 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. |
| Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children | 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
| Measure | Time frame | Description |
|---|---|---|
| The Gastrointestinal Symptom Rating Scale | 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). |
| Clinical Global Impressions-Improvement | 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. |
| Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome. | 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. |
| Conners' Parent Rating Scale-Revised (CPRS-R) | 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. |
| The Chinese version of Swanson, Nolan, and Pelham-IV (SNAP-IV) | 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). |
| The Sleep Disturbance Scale for Children | 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 |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Outcome results
None listed