2025-524673-16-00招募中2 期
Effect of faecal microbiota transplant on the expression of autism spectrum disorder core symptoms in children – open-label phase II clinical trial (FMT-PAS)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The treatment response (improvement/worsening) will be defined as ± 2 calibrated severity scores (CSS) in ADOS-2, Module 1 examination, which quantifies core symptoms intensity.
研究概览
简要总结
The primary objective of the trial is to describe the effect of faecal microbiota transplant (FMT) on autism spectrum disorder core symptoms.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 3–12 years
- •Diagnosis of ASD confirmed by a clinical psychologist or psychiatrist
- •Previous ADOS-2 examination result in the ASD range
- •Only minimum verbal ability (i.e. corresponding to ADOS-2, Module 1)
- •Informed consent of the parent (legal representative) and willingness to follow all planned study visits and instructions, especially for bowel preparation
排除标准
- •Congenital GIT defect or primary GIT disease, incl. medically confirmed coeliac disease (gluten enteropathy)
- •Newly initiated or recently changed formal behavioural, cognitive or cognitive-behavioural therapy (less than 30 days before enrolment)
- •Early reaction to food in the patient’s medical history
- •Expected inability to undergo bowel preparation (e.g. child’s inability to use liquid medication declared by parent)
- •Contraindication for common sedative medication, or serious complications of sedation in the patient’s medical history
- •Use of systemic immunosuppressants at present or in the last 3 months, or present medically confirmed immunocompromised status
- •Use of antiplatelet drugs, anticoagulants, or systemic antibiotics at present or in the last 3 months
- •Use of probiotics, prebiotics, or postbiotics at present or in the last 3 months
- •Severe co-morbid conditions (e.g. psychosis, epilepsy uncontrolled by medication, presence of severe visual or hearing impairment) that may interact with study procedures (at discretion of the investigator)
- •Newly initiated or recently changed pharmacotherapy (less than 30 days before enrolment)
研究组 & 干预措施
SUSPENSION FOR FAECAL MICROBIOTA TRANSPLANTATION
Test
干预措施: SUSPENSION FOR FAECAL MICROBIOTA TRANSPLANTATION (Drug)
结局指标
主要结局
The treatment response (improvement/worsening) will be defined as ± 2 calibrated severity scores (CSS) in ADOS-2, Module 1 examination, which quantifies core symptoms intensity.
The treatment response (improvement/worsening) will be defined as ± 2 calibrated severity scores (CSS) in ADOS-2, Module 1 examination, which quantifies core symptoms intensity.
次要结局
- Adverse events of FMT
- Bristol stool scale score, ATN-GISSI-17 questionnaire score
- PEDS-QL questionnaire score
- Scores in CARS2, SEQ and SDQ questionnaires
研究者
Regina Demlová
Scientific
Masarykova Univerzita
研究点 (1)
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