Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

The Third Affiliated Hospital of Southern Medical University10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Fecal Microbiota Transplantation (FMT)BIOLOGICAL

FMT will be performed through transendoscopic enteral tubing (TET) within one week during treatment period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.)

Locations (1)

The third affiliated hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Changes in mean amplitude of glycemic excursion (MAGE)

Dates from Continuous glucose monitoring system

Time frame: 24 Weeks

Changes in standard deviation of blood glucose (SDBG)

Dates from Continuous glucose monitoring system

Time frame: 24 Weeks

Changes in hemoglobin A1c (HbA1c)

Dates from blood chemistry test

Time frame: 24 Weeks

Safety of FMT

Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03

Time frame: 24 Weeks

Secondary Outcomes

Changes in 24h mean blood glucose(MBG)

Dates from Continuous glucose monitoring system

Time frame: 24 Weeks

Changes in percentage of time of blood glucose(PT)

Dates from Continuous glucose monitoring system

Time frame: 24 Weeks

Changes in mean absolute glucose(MAG)

Dates from Continuous glucose monitoring system

Time frame: 24 Weeks

Changes in standard deviation of blood glucose(SDBG)

Dates from Continuous glucose monitoring system

Time frame: 24 Weeks

Changes in coefficient of variation(CV)

Central Contacts

Daoyan Pan, MD

CONTACT

0086-02062784353 pdy4266@126.com

Data from ClinicalTrials.gov

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