Efficacy and Safety of Washed Microbiota Transplantation for Tourette's Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The change of Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS)
研究概览
简要总结
This study aimed to evaluate the efficacy of washed microbiota transplantation in the treatment of Tourette's syndrome (TS).
详细描述
Emerging scientific data support the significant role of microbiota in the modulation of the central nervous system. The reconstitution of gut microbiota might be a potential option to treat Tourette's syndrome (TS). FMT has been reported to be a highly effective therapy to restore the gut microbiota dysbiosis by transferring gut microbiota from healthy donors to patients. The newly improved methodology of FMT based on the automatic washing process and the related delivering consideration was named as washed microbiota transplantation (WMT) by the FMT-standardization study group. FMT has shown treatment potential in several gut-brain axis-related disorders, such as amyotrophic lateral sclerosis and Parkinson's disease, promoting us to investigate its treatment potential for Tourette's syndrome. In this study, investigators aimed to evaluate the efficacy of WMT for Tourette's syndrome and its comorbidities using specialized questionnaires for Tourette's syndrome and investigate the underlying mechanism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients were aged 6 to 17 years (inclusive);
- •Met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for TS;
- •Had a Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) of at least 20 at screening and baseline.
- •Underwent WMT.
排除标准
- •Complicated with certain brain disease, including tumor,injury,cerebrovascular disease;
- •Complicated with other severe disease, including cancers, organ failure, heart diseases;
- •Stereotypy associated with autism spectrum disorder;
- •With a confirmed diagnosis of psychiatric diseases, such as bipolar disorders; schizophrenia and major depressive disorders;
- •Clinically significant obsessive-compulsive disorder at baseline considered to be the primary cause of impairment at baseline;
- •Medications use affecting gut microbiota such as antibiotics and probiotics three months before WMT.
- •Other neurologic disorders other than TS that could influence the evaluation of tics.
研究组 & 干预措施
Washed microbiota transplantation
WMT
干预措施: Washed Microbiota Transplantation (Drug)
结局指标
主要结局
The change of Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS)
时间窗: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
The YGTSS rating scale is a semistructured clinician- or investigator-administered rating instrument in which participants or caregivers evaluate the number, frequency, intensity, complexity, and interference of motor and phonic tics in the prior week on a 6-point scale from 0 (none) to 5 (severe) \[1\]. The total Motor Tic Severity Score (MTSS; 0-25 points) is added to the total Vocal Tic Severity Score (VTSS; 0-25 points) to determine the TTS (0-50 points).
次要结局
- the change of Gilles de la Tourette Syndrome Quality-of-Life Scale score(baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation)
- change of the Sleep Disturbance Scale for Children (SDSC)(baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation)
- change of the Gastrointestinal Symptom Rating Scale (GSRS) .(baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation)
- the Clinical Global Impressions-Improvement scale(4 weeks, 8 weeks, 12 weeks, 6 months post transplantation)
- the difference of the gut microbe composition between individuals with TS and healthy children by sequencing faecal metagenome.(baseline, 12 weeks, 6 months post transplantation)
- the change of The Swanson, Nolan, and Pelham IV Scale (SNAP-IV)(baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University