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Randomised Placebo-controlled Study of FMT to Impact Body Weight and Glycemic Control in Obese Subjects With T2DM

NCT03127696 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-02-15

No results posted yet for this study

Summary

Faecal microbiota transplantation (FMT) represents a clinically feasible way to restore the gut microbial ecology, and has proven to be a breakthrough for the treatment of recurrent Clostridium difficile infection. Early results in human have shown that FMT from lean donor when transplanted into subjects with metabolic syndrome resulted in a significant improvement in insulin sensitivity and an increased in intestinal microbial diversity, including a distinct increase in butyrate-producing bacterial strains. The therapy is generally well tolerated and appeared safe. No clinical studies have assessed the efficacy of FMT in obese subjects with type 2 diabetes mellitus.

Conditions

Interventions

PROCEDURE

Fecal Microbiota Transplantation

FMT

BEHAVIORAL

Lifestyle Modification Program

Lifestyle

PROCEDURE

Sham

Sham

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Siew NG, Prof. · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-26
Primary Completion
2019-05-15
Completion
2019-12-06

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03127696 on ClinicalTrials.gov