NCT06256614招募中不适用
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus: a Real World Research
The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The mean daily insulin dosage of participants
研究概览
简要总结
This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation (WMT) for patients with Type 1 Diabetes Mellitus (T1DM).
详细描述
At least 20 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, blood glucose fluctuation and variability, daily insulin dosage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to enter the study:
- •At the time of informed consent, male or non-pregnant or non-lactating female.
- •The diagnostic criteria for T1DM are confirmed by previous medical record.
- •The subject or his/her legal representative gives informed consent, fully nderstands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.
排除标准
- •Subjects meeting any of the following exclusion criteria must be excluded from the study:
- •Diagnosed as any type of diabetes other than type 1 diabetes mellitus;
- •Subjects with severe life-threatening complications diabetes (such as ketoacidosis, or acute coronary syndrome, etc.);
- •At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
- •According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.
结局指标
主要结局
The mean daily insulin dosage of participants
时间窗: One-week, Two-week, Four-week post-WMT
The mean daily insulin dosage of participants in past week
次要结局
- The Blood glucose of Time in Range (TIR, percent) of type 1 diabetes mellitus.(One-week, Two-week, Four-week post-WMT)
- The SD of blood glucose (SDBG, mmol/L) of type 1 diabetes mellitus.(One-week, Two-week, Four-week post-WMT)
- The largest amplitude of glycemic excursions (LAGE, mmol/L) of type 1 diabetes mellitus.(One-week, Two-week, Four-week post-WMT)
- The mean amplitude of glycemic excursion (MAGE, mmol/L) of type 1 diabetes mellitus.(One-week, Two-week, Four-week post-WMT)
- The mean of daily differences (MODD, mmol/L) of type 1 diabetes mellitus.(One-week, Two-week, Four-week post-WMT)
- The postprandial glucose excursions (PPGE, mmol/L) of type 1 diabetes mellitus.(One-week, Two-week, Four-week post-WMT)
- The mean blood glucose (MBG, mmol/L) of type 1 diabetes mellitus.(One-week, Two-week, Four-week post-WMT)
- The coefficient of variation (CV, percent) of type 1 diabetes mellitus.(One-week, Two-week, Four-week post-WMT)
- The frequency of hypoglycemia or duration of hypoglycemic state in the last 1 week(One-week, Two-week, Four-week post-WMT)
- The islet β-cell function after WMT compared with baseline(Three-day, One-week, Two-week, Four-week post-WMT)
- The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0(One-week, Two-week, Four-week post-WMT)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University
研究点 (1)
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