WMT for Autism Spectrum Disorder (ASD)
- Conditions
- Autism Spectrum Disorder
- Interventions
- Registration Number
- NCT06030752
- Lead Sponsor
- The Second Hospital of Nanjing Medical University
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Children who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for at least 3 months.
- Age 3-14years.
- Received WMT
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Washed microbiota transplantation Washed Microbiota Transplantation WMT
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method Parental Global Impressions-Revised 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.
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.
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).
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
Trial Locations
- Locations (2)
SIR RUN RUN hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China