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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:
ClinicalTrials.gov Identifier:
NCT01790711
First Posted: February 13, 2013
Last Update Posted: November 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University
  Purpose
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.

Condition Intervention Phase
Efficiency Methodology Procedure: FMT through mid-gut Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficiency of Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Faming Zhang, The Second Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FMT by endoscopy
Once, fresh or frozen bacteria
Procedure: FMT through mid-gut
Other Name: FMT through mid-gut by gastroscope

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790711


Locations
China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
  More Information

Additional Information:
Publications:
Responsible Party: Faming Zhang, Vice chief, medical center for digestive diseases, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01790711     History of Changes
Other Study ID Numbers: FMT-CN-121025
First Submitted: February 9, 2013
First Posted: February 13, 2013
Last Update Posted: November 24, 2014
Last Verified: November 2014

Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
Gut bacteria
Bacteria
Fecal transplant
Bacteriotherapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases