Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-25

Study Completion Date

2020-03-10

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.

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FMT Arm

10 Participants will be enrolled in this arm to receive FMT treatment

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation (FMT)

Intervention Type BIOLOGICAL

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

Interventions

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Fecal Microbiota Transplantation (FMT)

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

Intervention Type BIOLOGICAL

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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No