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Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Faming Zhang, The Second Hospital of Nanjing Medical University.
Recruitment status was:  Enrolling by invitation
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01790711
First received: February 9, 2013
Last updated: November 21, 2014
Last verified: November 2014
February 9, 2013
November 21, 2014
October 2012
May 2015   (Final data collection date for primary outcome measure)
The Efficiency of FMT on T2DM [ Time Frame: Up to 24 months ]
Confirmed by the tests of blood glucose level, OGTT, HACb1 and C-peptide.
The Efficiency of FMT on T2DM [ Time Frame: Up to 12 months ]
Confirmed by the tests of blood glucose level, OGTT, HACb1 and C-peptide.
Complete list of historical versions of study NCT01790711 on ClinicalTrials.gov Archive Site
Durability [ Time Frame: Up to 12 months ]
Measure the durability of the therapy effects.Based on the tests of blood glucose level, HACb1 and C-peptide. BMI also will be observed.
Same as current
Not Provided
Not Provided
 
Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus
The Efficiency of 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.
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.
Interventional
Phase 2
Phase 3
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Efficiency
  • Methodology
Procedure: FMT through mid-gut
Other Name: FMT through mid-gut by gastroscope
Experimental: FMT by endoscopy
Once, fresh or frozen bacteria
Intervention: Procedure: FMT through mid-gut

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
June 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Type 2 diabetes mellitus

Exclusion Criteria:

With any cause of liver disease other than fatty liver Known or suspected cirrhosis Inability or unwillingness to undergo OGTT and magnetic resonance procedures Requirement of long-term antibiotic therapy Pregnancy, breast-feeding, or plans to become pregnant

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01790711
FMT-CN-121025
Yes
Not Provided
Not Provided
Faming Zhang, The Second Hospital of Nanjing Medical University
The Second Hospital of Nanjing Medical University
Not Provided
Not Provided
The Second Hospital of Nanjing Medical University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP