Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

Phase 2

• Conditions: Methodology; Efficiency
• Interventions: Procedure: FMT through mid-gut

• Registration Number: NCT01790711
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-02-09
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-21
• Last Update Posted: 2014-11-24
• Primary Completion: 2015-05
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT by endoscopy	FMT through mid-gut	Once, fresh or frozen bacteria

Primary Outcome Measures

Name	Time	Method
The Efficiency of FMT on T2DM	Up to 24 months	Confirmed by the tests of blood glucose level, OGTT, HACb1 and C-peptide.

Secondary Outcome Measures

Name	Time	Method
Durability	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.

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China