Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

N

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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