Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

The Efficiency of Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790711

Enrollment

Registered

2013-02-13

Start date

2012-10-31

Completion date

2015-06-30

Last updated

2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficiency, Methodology

Keywords

Gut bacteria, Bacteria, Fecal transplant, Bacteriotherapy

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.

Interventions

PROCEDUREFMT through mid-gut

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026