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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790711
|Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University|
|Nanjing, Jiangsu, China, 210011|