Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in mean amplitude of glycemic excursion (MAGE)
研究概览
简要总结
This study intends to reconstruct intestinal micro-ecology through fecal Microbiome transplantation (FMT) technology, to treat patients with type 1 diabetes, and combine intestinal Metagenomics and 16s rRNA sequencing technology to study the relevant mechanism of intestinal micro-ecology for the treatment of type 1 diabetes.
详细描述
Type 1 diabetes is an organ-specific autoimmune disease based on islet beta cell-specific destruction and absolute insulin deficiency. Studies on the pathogenesis of intestinal flora and type 1 diabetes have shown that as an "endocrine organ", intestinal microbes play an important role in regulating the secretion of the body. Bacteria in the intestine can not only directly synthesize hormones or hormone-like compounds, but also regulate the synthesis and secretion of corresponding hormones in the widely distributed intestinal endocrine cells, thereby participating in the regulation of various biological functions in the human body. This study uses fecal microbiome transplantation (FMT) to explore another potential treatment for type 1 diabetes.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Type 1 diabetes patients.
- •(2) Age between 18 and 65 years old, regardless of gender.
- •(3) No serious comorbidities.
- •(4) Accept and suitable for endoscopic catheterization (TET) and fecal transplantation (FMT).
- •(5) Can receive follow-up and follow-up examinations on time. (6) Subjects need to sign an informed consent form.
排除标准
- •(1) Systematic application of glucocorticoids, other immunosuppressive drugs or biological immune modulators, antibiotics, probiotics, and other microecological agents to alter intestinal motility within 6 months prior to enrollment.
- •(2) An infection that is active.
- •(3) Combined with irritable bowel syndrome, inflammatory bowel disease, celiac disease, and other chronic gastrointestinal diseases, the condition has not been controlled.
- •(4) Chronic diseases such as cerebrovascular disease, cardiovascular disease, and diabetic autonomic neuropathy.
- •(5) Pregnancy or with a pregnancy plan
- •(6) severe organ dysfunction (including decompensated cirrhosis, malignant tumors, etc.)
研究组 & 干预措施
FMT Arm
10 Participants will be enrolled in this arm to receive FMT treatment
干预措施: Fecal Microbiota Transplantation (FMT) (Biological)
结局指标
主要结局
Changes in mean amplitude of glycemic excursion (MAGE)
时间窗: 24 Weeks
Dates from Continuous glucose monitoring system
Changes in standard deviation of blood glucose (SDBG)
时间窗: 24 Weeks
Dates from Continuous glucose monitoring system
Changes in hemoglobin A1c (HbA1c)
时间窗: 24 Weeks
Dates from blood chemistry test
Safety of FMT
时间窗: 24 Weeks
Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03
次要结局
- Changes in 24h mean blood glucose(MBG)(24 Weeks)
- Changes in percentage of time of blood glucose(PT)(24 Weeks)
- Changes in mean absolute glucose(MAG)(24 Weeks)
- Changes in standard deviation of blood glucose(SDBG)(24 Weeks)
- Changes in coefficient of variation(CV)(24 Weeks)
- Changes in high blood glucose index(HBGI)(24 Weeks)
- Changes in low blood glucose index(LBGI)(24 Weeks)
- Changes in effective blood glucose fluctuations in frequency(NGE)(24 Weeks)
- Changes in glycated albumin (GA)(24 Weeks)
- Changes of serum C-peptide (fasting, 30min after meal, 120min after meal)(24 Weeks)
- Assessment of diabetes antibodies(24 Weeks)
- Changes in intestinal microbiome profile(24 Weeks)
- Changes in Peripheral Blood Stem Cell (PBMC)(24 Weeks)
- Changes in body weight to calculate body mass index (BMI)(24 Weeks)
- Pathological changes of intestinal mucosa(24 Weeks)
- Changes in blood pressure(24 Weeks)
- Changes in oral mucosal bacteria colonization(24 Weeks)
- Changes in urine microalbumin(24 Weeks)
- Blood chemistry panel(24 Weeks)
研究者
Jie Shen
MD, Director of Endocrinology
The Third Affiliated Hospital of Southern Medical University