NCT06340828尚未招募不适用
Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study
The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gut Microbiome Sequencing
研究概览
简要总结
The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:
- The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests.
- The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria.
- The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes.
- The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.
Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
- •Glycated hemoglobin (HbA1c) < 11.0%.
排除标准
- •Insulin dependent diabetes;
- •Active infections, antibiotics-using, inflammatory bowel disease, irritable bowel syndrome, or other severe gastrointestinal organic disease;
- •Severe diabetic complications;
- •Thyroid disease, malignancies, severe cognitive impairment and mental disease;
- •Alcohol or substance abuse;
- •Pregnancy or lactation.
结局指标
主要结局
Gut Microbiome Sequencing
时间窗: 0 days，weeks 12 post-treatment
16S rRNA Sequencing
Gastrointestinal Symptom Rating Scale
时间窗: 0 days，weeks 1, 4, and 12 post-treatment
Questionnaires，the minimum score is 0，and maximum is 45, and higher scores mean a worse outcome.
次要结局
- Serum Metabolites(0 days，weeks 12 post-treatment)
- Gastrointestinal Motility(0 days，weeks 12 post-treatment)
- Gastroparesis Cardinal Symptom Index(0 days，weeks 1, 4, and 12 post-treatment)
- Composite Autonomic Symptom Score 31(0 days，weeks 1, 4, and 12 post-treatment)
- Heart Rate Variability(0 days，weeks 12 post-treatment)
研究者
研究点 (1)
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