WMT for Autism Spectrum Disorder (ASD)
ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-17
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children and adolescents with an established diagnosis of ASD 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
Disqualifiers
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.
Trial population
Children and adolescents with an established diagnosis of ASD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Washed Microbiota Transplantation
DrugThe prepared microbiota suspension was infused into the participates' lower gut.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Washed microbiota transplantation1 intervention
Trial outcomes
Primary outcomes
1
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 transplantation2
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 transplantationSecondary outcomes
1
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.2
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 transplantation3
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 transplantation4
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 transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Second Hospital of Nanjing Medical University
Lead sponsor
Nanjing Medical University
Collaborator
Source ClinicalTrials.gov