Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Biological: Fecal Microbiota Transplantation (FMT)


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT Arm<br>10 Participants will be enrolled in this arm to receive FMT treatment | Biological: Fecal Microbiota Transplantation (FMT)<br>* FMT will be performed through transendoscopic enteral tubing (TET) within one week during treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean amplitude of glycemic excursion (MAGE) | Dates from Continuous glucose monitoring system | 24 Weeks | 
| Changes in standard deviation of blood glucose (SDBG) | Dates from Continuous glucose monitoring system | 24 Weeks | 
| Changes in hemoglobin A1c (HbA1c) | Dates from blood chemistry test | 24 Weeks | 
| Safety of FMT | Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03 | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 24h mean blood glucose(MBG) | Dates from Continuous glucose monitoring system | 24 Weeks | 
| Changes in percentage of time of blood glucose(PT) | Dates from Continuous glucose monitoring system | 24 Weeks | 
| Changes in mean absolute glucose(MAG) | Dates from Continuous glucose monitoring system | 24 Weeks | 
| Changes in standard deviation of blood glucose(SDBG) | Dates from Continuous glucose monitoring system | 24 Weeks | 
| Changes in coefficient of variation(CV) | Dates from Continuous glucose monitoring system | 24 Weeks | 
| Changes in high blood glucose index(HBGI) | Dates from Continuous glucose monitoring system | 24 Weeks | 
| Changes in low blood glucose index(LBGI) | Dates from Continuous glucose monitoring system | 24 Weeks | 
| Changes in effective blood glucose fluctuations in frequency(NGE) | Dates from Continuous glucose monitoring system | 24 Weeks | 
| Changes in glycated albumin (GA) | Dates from blood chemistry test | 24 Weeks | 
| Changes of serum C-peptide (fasting, 30min after meal, 120min after meal) | Dates from blood chemistry test | 24 Weeks | 
| 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 | 
| Changes in intestinal microbiome profile | Changes in intestinal microbiome profile by 16s rRNA sequencing and metagenomics. | 24 Weeks | 
| Changes in Peripheral Blood Stem Cell (PBMC) | Dates from blood test | 24 Weeks | 
| Changes in body weight to calculate body mass index (BMI) | Dates from physical examination | 24 Weeks | 
| Pathological changes of intestinal mucosa | Changes in intestinal mucosa profile by enteroscopy | 24 Weeks | 
| Changes in blood pressure | Dates from physical examination | 24 Weeks | 
| Changes in oral mucosal bacteria colonization | Changes in oral mucosal bacteria by 16s rRNA sequencing and metagenomics. | 24 Weeks | 
| Changes in urine microalbumin | Dates from urine test | 24 Weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Microbiome Transplantation (FMT)