Autism Spectrum Disorder ASD, Autism Spectrum Disorder
Conditions
Interventions
1. Administration schedule of the SHIN-1
containing solution.
The SHIN-1 containing solution is administered
rectally once a week for 6 consecutive weeks.
The efficacy will be evaluated with the re
Sponsors
Tanaka Yoshimu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children between the ages of 5 and 12, regardless of gender, who have recently been diagnosed with ASD by a board-certified pediatric neurologist of The Japanese Society of Child Neurology, a board-certified psychiatrist of The Japanese Society for Psychiatry and Neurology, a board-certified member of The Japanese Society for Child and Adolescent Psychiatry, or a board-certified member of Japanese Society of Pediatric Psychiatry and Neurology. 2. Generally good physical health aside from gastrointestinal problems. 3. Children who are able to give informed assent to take part in the clinical study. 4. Children who are able to obtain informed consent from their legally authorized representatives to take part in the clinical study.
Exclusion criteria
Exclusion criteria: 1. Currently on treatment with medicines. 2. Received antibiotics (excluding topical antibiotics) within the last three months. 3. Received fecal microbiota transplantation within the last 12 months. 4. Children with a single gene disorder (Fragile X, Rett Syndrome, Joubert Syndrome, etc. which may affect the evaluation of ASD). 5. Children with neurosurgical or neurological diseases. 6. Currently on tube feeding. 7. Severely underweight and malnourished less than 65% of a standard body weight. 8. Had surgery within the last 12 months or are scheduled to have surgery within the next six months. 9. Current participation in other clinical trials. 10. Children who are judged by a principal investigator to be unsuitable for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. SRS-2 1) Changes in the severities of ASD and its core symptoms before and after the FMT are evaluated by SRS-2. 2) Evaluation timings are as follows: at the time before the FMT and at 6, 10, 14, 18, and 30 weeks after the FMT. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gazefinder. A change in the ASD severity before and after the FMT is evaluated by the gaze rates for specific areas on the screen of Gazefinder. Evaluation timings are as follows: at the time before the FMT and at 30 weeks after the FMT. 2. PHQ-4. The PHQ-4 is a questionnaire consisting of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). Changes in the key symptoms and the signs of depression and anxiety before and after the FMT are evaluated by a combined assessment of the PHQ-2 and the GAD-2 scores. Evaluation timings are as follows: at the time before the FMT and at 6, 10, 14, 18, and 30 weeks after the FMT. 3. GSRS. The GSRS is a 15-item questionnaire to evaluate gastrointestinal symptoms which include acid reflux (2 tems), abdominal pain (3 items), indigestion symptoms (4 items), diarrhea (3 items), and constipation (3items). A change in the gastrointestinal symptoms before and after the FMT is evaluated by the combination of the scores of these items. Evaluation timings are as follows: at the time before the FMT and at 6, 10, 14, 18, and 30 weeks after the FMT. 4. BS score. The BS scores are one of the diagnostic items for constipation or diarrhea, which are classified into 7 categories based on the shape, color, and hardness of stools. A change of constipation or diarrhea before and after the FMT is evaluated by this score. Evaluation timings are as follows: at the time before the FMT and at 6, 10, 14, 18, and 30 weeks after the FMT. 5. The number and frequency of adverse events. Adverse events are evaluated at the time when they are observed. 6. SSP (Short Sensory Profile) Changes in the sensory symptoms (sensory hypersensitivity, sensory numbness, and under-responsive/sensation seeking) before and after the implementation of FMT, are evaluated based on the scores of the seven items of tactile hypersensitivity, taste/smell hypersensitivity, movement hypersensitivity, under-responsive/ sensation se | — |
Contacts
Public ContactYoshimu Tanaka
Jinzenkai Medical Corporation Tanaka Medical Clinic
Outcome results
None listed