JPRN-jRCTs031230041进行中（未招募）Unknown
A Clinical Study on the Efficacy and Safety of a New Method of Fecal Microbiota Transplantation (FMT) for Treatment of Autism Spectrum Disorder (ASD)
Tanaka Yoshimu0 个研究点目标入组 30 人开始时间: 2023年4月18日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 5age old 至 <= 12age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
- •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.
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