Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

This study is enrolling participants by invitation only.
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: December 15, 2013
Last verified: December 2013

February 9, 2013
December 15, 2013
October 2012
December 2014   (final data collection date for primary outcome measure)
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.
The Efficiency of FMT on T2DM [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
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 ] [ 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.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Enrolling by invitation
30
December 2014
December 2014   (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

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01790711
FMT-CN-121025
Yes
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
December 2013

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