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ASD FMT Clinical Research

Not Applicable
Conditions
Autism Spectrum Disorder
ASD, Autism Spectrum Disorder
D000067877
Registration Number
JPRN-jRCTs031230041
Lead Sponsor
Tanaka Yoshimu
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
30
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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