Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Biological: Fecal Microbiota Transplantation (FMT)
- Registration Number
- NCT04124211
- Lead Sponsor
- The Third Affiliated Hospital of Southern Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- (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.
- (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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FMT Arm Fecal Microbiota Transplantation (FMT) 10 Participants will be enrolled in this arm to receive FMT treatment
- Primary Outcome Measures
Name Time Method Changes in mean amplitude of glycemic excursion (MAGE) 24 Weeks Dates from Continuous glucose monitoring system
Changes in standard deviation of blood glucose (SDBG) 24 Weeks Dates from Continuous glucose monitoring system
Changes in hemoglobin A1c (HbA1c) 24 Weeks Dates from blood chemistry test
Safety of FMT 24 Weeks Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03
- Secondary Outcome Measures
Name Time Method Changes in 24h mean blood glucose(MBG) 24 Weeks Dates from Continuous glucose monitoring system
Changes in percentage of time of blood glucose(PT) 24 Weeks Dates from Continuous glucose monitoring system
Changes in mean absolute glucose(MAG) 24 Weeks Dates from Continuous glucose monitoring system
Changes in standard deviation of blood glucose(SDBG) 24 Weeks Dates from Continuous glucose monitoring system
Changes in coefficient of variation(CV) 24 Weeks Dates from Continuous glucose monitoring system
Changes in high blood glucose index(HBGI) 24 Weeks Dates from Continuous glucose monitoring system
Changes in low blood glucose index(LBGI) 24 Weeks Dates from Continuous glucose monitoring system
Changes in effective blood glucose fluctuations in frequency(NGE) 24 Weeks Dates from Continuous glucose monitoring system
Changes in glycated albumin (GA) 24 Weeks Dates from blood chemistry test
Changes of serum C-peptide (fasting, 30min after meal, 120min after meal) 24 Weeks Dates from blood chemistry test
Assessment of diabetes antibodies 24 Weeks 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);
Changes in intestinal microbiome profile 24 Weeks Changes in intestinal microbiome profile by 16s rRNA sequencing and metagenomics.
Changes in Peripheral Blood Stem Cell (PBMC) 24 Weeks Dates from blood test
Changes in body weight to calculate body mass index (BMI) 24 Weeks Dates from physical examination
Pathological changes of intestinal mucosa 24 Weeks Changes in intestinal mucosa profile by enteroscopy
Changes in blood pressure 24 Weeks Dates from physical examination
Changes in oral mucosal bacteria colonization 24 Weeks Changes in oral mucosal bacteria by 16s rRNA sequencing and metagenomics.
Changes in urine microalbumin 24 Weeks Dates from urine test
Blood chemistry panel 24 Weeks 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.
Trial Locations
- Locations (1)
The third affiliated hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China