NCT01790711

Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

The Efficiency of Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Efficiency
• Methodology

Interventions

Type	Name	Description
PROCEDURE	FMT through mid-gut

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2013-02-13
• Last updated: 2014-11-24

Locations

1 site across 1 country: China