Status:
UNKNOWN
Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
Lead Sponsor:
The Third Affiliated Hospital of Southern Medical University
Collaborating Sponsors:
Southern Medical University, China
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
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 16...
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 diabet...
Eligibility Criteria
Inclusion
- (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
- (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.)
Key Trial Info
Start Date :
August 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04124211
Start Date
August 25 2019
End Date
March 10 2020
Last Update
October 11 2019
Active Locations (1)
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1
The third affiliated hospital of Southern Medical University
Guangzhou, Guangdong, China, 510630