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Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01790711
Recruitment Status : Unknown
Verified November 2014 by Faming Zhang, The Second Hospital of Nanjing Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : February 13, 2013
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE February 9, 2013
First Posted Date  ICMJE February 13, 2013
Last Update Posted Date November 24, 2014
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
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.
Change History Complete list of historical versions of study NCT01790711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus
Official Title  ICMJE The Efficiency of Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Efficiency
  • Methodology
Intervention  ICMJE Procedure: FMT through mid-gut
Other Name: FMT through mid-gut by gastroscope
Study Arms  ICMJE Experimental: FMT by endoscopy
Once, fresh or frozen bacteria
Intervention: Procedure: FMT through mid-gut
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 11, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01790711
Other Study ID Numbers  ICMJE FMT-CN-121025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Faming Zhang, The Second Hospital of Nanjing Medical University
Study Sponsor  ICMJE The Second Hospital of Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Second Hospital of Nanjing Medical University
Verification Date November 2014

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