Type 1 Diabetes Clinical Trial
Official title:
Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | March 10, 2020 |
Est. primary completion date | March 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - (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. Exclusion Criteria: - (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.) |
Country | Name | City | State |
---|---|---|---|
China | The third affiliated hospital of Southern Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
The Third Affiliated Hospital of Southern Medical University | Southern Medical University, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in mean amplitude of glycemic excursion (MAGE) | Dates from Continuous glucose monitoring system | 24 Weeks | |
Primary | Changes in standard deviation of blood glucose (SDBG) | Dates from Continuous glucose monitoring system | 24 Weeks | |
Primary | Changes in hemoglobin A1c (HbA1c) | Dates from blood chemistry test | 24 Weeks | |
Primary | Safety of FMT | Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03 | 24 Weeks | |
Secondary | Changes in 24h mean blood glucose(MBG) | Dates from Continuous glucose monitoring system | 24 Weeks | |
Secondary | Changes in percentage of time of blood glucose(PT) | Dates from Continuous glucose monitoring system | 24 Weeks | |
Secondary | Changes in mean absolute glucose(MAG) | Dates from Continuous glucose monitoring system | 24 Weeks | |
Secondary | Changes in standard deviation of blood glucose(SDBG) | Dates from Continuous glucose monitoring system | 24 Weeks | |
Secondary | Changes in coefficient of variation(CV) | Dates from Continuous glucose monitoring system | 24 Weeks | |
Secondary | Changes in high blood glucose index(HBGI) | Dates from Continuous glucose monitoring system | 24 Weeks | |
Secondary | Changes in low blood glucose index(LBGI) | Dates from Continuous glucose monitoring system | 24 Weeks | |
Secondary | Changes in effective blood glucose fluctuations in frequency(NGE) | Dates from Continuous glucose monitoring system | 24 Weeks | |
Secondary | Changes in glycated albumin (GA) | Dates from blood chemistry test | 24 Weeks | |
Secondary | Changes of serum C-peptide (fasting, 30min after meal, 120min after meal) | Dates from blood chemistry test | 24 Weeks | |
Secondary | Assessment of diabetes antibodies | Assessment of diabetes antibodies including Islet Cell Cytoplasmic Autoantibodies (ICA), Insulin Autoantibodies (IAA), Glutamic Acid Decarboxylase Autoantibodies (GADA), Insulinoma-Associated-2 Autoantibodies (IA-2A), and Zinc Transporter-8 Autoantibodies (ZnT8A); | 24 Weeks | |
Secondary | Changes in intestinal microbiome profile | Changes in intestinal microbiome profile by 16s rRNA sequencing and metagenomics. | 24 Weeks | |
Secondary | Changes in Peripheral Blood Stem Cell (PBMC) | Dates from blood test | 24 Weeks | |
Secondary | Changes in body weight to calculate body mass index (BMI) | Dates from physical examination | 24 Weeks | |
Secondary | Pathological changes of intestinal mucosa | Changes in intestinal mucosa profile by enteroscopy | 24 Weeks | |
Secondary | Changes in blood pressure | Dates from physical examination | 24 Weeks | |
Secondary | Changes in oral mucosal bacteria colonization | Changes in oral mucosal bacteria by 16s rRNA sequencing and metagenomics. | 24 Weeks | |
Secondary | Changes in urine microalbumin | Dates from urine test | 24 Weeks | |
Secondary | Blood chemistry panel | Changes in the results of blood chemistry tests including complete blood count, diabetic autoantibodies, serum C peptide, insulin, blood glucose, routine urine, urinary microalbumin, routine stool, liver function, renal function, seven ions, myocardial enzymes, six glycolipids, glycated hemoglobin and glycosylated serum albumin before and after treatment. | 24 Weeks |
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