Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the body's metabolism. Evidence from animal and human studies strongly support the link between intestinal bacteria and type 2 diabetes mellitus. The present clinical trial aims to re-establish a gut functionality state of intestinal flora through fecal microbiota transplantation.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficiency of Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus|
- The Efficiency of FMT on T2DM [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]Confirmed by the tests of blood glucose level, OGTT, HACb1 and C-peptide.
- Durability [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]Measure the durability of the therapy effects.Based on the tests of blood glucose level, HACb1 and C-peptide. BMI also will be observed.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: FMT by endoscopy
Once, fresh or frozen bacteria
Procedure: FMT through mid-gut
Other Name: FMT through mid-gut by gastroscope
We established a standard bacteria isolation from donated fresh stool in lab.Then the bacteria is transplanted to mid-gut (at least below the second part of duodenum ) through regular gastroscope. Participants in this study will be randomly assigned to receive fecal microbiota transplantation only once or traditional therapy, and accept follow-up for at least one year. Blood tests,OGTT and magnetic resonance spectroscopy will be used to assess participants at study start and at study completion.
|Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University|
|Nanjing, Jiangsu, China, 210011|