Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

The Third Affiliated Hospital of Southern Medical University

Status

Unknown

Conditions

Type 1 Diabetes

Treatments

Biological: Fecal Microbiota Transplantation (FMT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04124211

NYSY-NFM

2018-lunshen-017 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.)