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
  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: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
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)
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 9, 2013
Last Updated: December 15, 2013
Health Authority: China: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on October 19, 2014