Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

Nanjing Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Methodology; Efficiency

Treatments: Procedure: FMT through mid-gut

Study type: Interventional

Funder types: Other

Identifiers

NCT01790711

FMT-CN-121025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

FMT by endoscopy

Experimental group

Description:

Once, fresh or frozen bacteria

Treatment:

Procedure: FMT through mid-gut