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

February 13, 2022 updated by: Siew Chien NG, Chinese University of Hong Kong

A Randomised Placebo-controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Obese Subjects With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is a worldwide epidemic of obesity and type 2 diabetes mellitus. The prevalence of obesity and type 2 diabetes mellitus continues to rise at an alarming rate. Weight loss is associated with reductions in risk of morbidity and mortality from obesity. Conventional non-pharmacological interventions based on diet and exercise showed limited long-term success in producing sustained weight loss. Although obese patients with type 2 diabetes mellitus may be treated by medications or by bariatric surgery, these alternatives are limited by incomplete resolution of the diseases, high cost or potential surgical-related morbidity. Further research focusing on increasing effectiveness of interventions and new ways to achieve weight loss in these individuals are needed.

Recently, accumulating evidence supports a role of the enteric microbiota in the pathogenesis of obesity-related insulin resistance. Obesity is associated with changes in the composition of the intestinal microbiota, and the obese microbiome appears to be more efficient in harvesting energy from the diet. Colonization of germ-free mice with an 'obese microbiota' results in a significantly greater increase in total body fat than colonization with a 'lean microbiota', suggesting gut microbiota as an additional contributing factor to the pathophysiology of obesity. Obese and lean phenotypes can also be induced in germ-free mice by transfer of fecal microbiota from human donors. These data have led to the use of microbiota therapeutics as a potential treatment for metabolic syndrome and obesity.

Clinical trials are being conducted to evaluate its use for other conditions. 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.

No clinical studies have assessed the efficacy of FMT in obese subjects with type 2 diabetes mellitus.

A subgroup of 30 subjects will be analyzed at week 24. The difference and proportion in microbiome in different arms, microbial factors, and trans-kingdom correlation of microbial engraftment will be correlated with clinical data in an unblinded manner.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Sha Tin, Hong Kong, 000000
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-70; and
  • BMI >=28 kg/m2 and < 45 kg/m2; and
  • A diagnosis of Type 2 diabetes mellitus for >=3 months; and
  • Written informed consent obtained

Exclusion Criteria:

  • Current pregnancy
  • Use of any weight loss medications in the preceding 1 year
  • Known history or concomitant significant gastrointestinal disorders (including Inflammatory Bowel Disease, current colorectal cancer, current GI infection)
  • Known history or concomitant significant food allergies
  • Immunosuppressed subjects
  • Known history of severe organ failure (including decompensated cirrhosis), inflammatory bowel disease, kidney failure, epilepsy, acquired immunodeficiency syndrome
  • Current active sepsis
  • Active malignant disease in recent 2 years
  • Known contraindications to oesophago-gastro-duodenoscopy (OGD)
  • Use of probiotic or antibiotics in recent 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FMT + LMP
FMT and lifestyle modification program
Procedure: Fecal Microbiota Transplantation
FMT
Behavioral: Lifestyle Modification Program
Lifestyle
Experimental: FMT alone
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
FMT
Sham Comparator: Sham + LMP
Sham and lifestyle modification program
Behavioral: Lifestyle Modification Program
Lifestyle
Procedure: Sham
Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with at least 20% lean-associated microbiota in recipients after FMT compared with subjects receiving lifestyle intervention alone up to week 24
Time Frame: 24 weeks
Proportion of subjects with at least 20% lean-associated microbiota in recipients after FMT compared with subjects receiving lifestyle intervention alone up to week 24.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in microbial composition (including bacteriome and virome), function and metabolite
Time Frame: 4, 16, 20, 24 week
Changes in microbial composition (including bacteriome and virome), function and metabolite at weeks 4, 16, 20 and 24 compared with baseline
4, 16, 20, 24 week
Changes in microbiome of stool (including bacteriome and virome)
Time Frame: 4, 16, 24 week
Changes in microbiome of stool (including bacteriome and virome) at weeks 4, 16 and 24 compared with baseline
4, 16, 24 week
Difference in microbiome (including bacteriome and virome) compared between subjects in different treatment arm
Time Frame: 24 week and 52 week
Compare the difference in microbiome among different treatment arms
24 week and 52 week
Proportion of microbiome (including bacteriome and virome) derived from recipient, donor or both in subjects who received FMT
Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52
Proportion of microbiome (including bacteriome and virome) derived from recipient, donor or both in subjects who received FMT
weeks 4, 8, 12, 16, 20, 24 and 52
Difference in microbiome (including bacteriome and virome) compared between subjects who have weight loss and those do not have weight loss
Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52
Difference in microbiome (including bacteriome and virome) compared between subjects who have weight loss and those do not have weight loss
weeks 4, 8, 12, 16, 20, 24 and 52
Microbial factors (including bacteriome and virome) that are associated with percentage of body weight loss
Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52
Microbial factors (including bacteriome and virome) that are associated with percentage of body weight loss
weeks 4, 8, 12, 16, 20, 24 and 52
Trans-kingdom correlation of microbial engraftment
Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52
Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, and virome
weeks 4, 8, 12, 16, 20, 24 and 52
Proportion of subjects with serious adverse events compared between treatment arm, especially those related to FMT
Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52
Proportion of subjects with serious adverse events compared between treatment arm, especially those related to FMT
weeks 4, 8, 12, 16, 20, 24 and 52
Explore changes in fungome microbiota
Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52
Explore changes in fungome microbiota
weeks 4, 8, 12, 16, 20, 24 and 52
Proportion of subjects achieving at least 10% reduction in weight compared with baseline
Time Frame: 52 weeks
Proportion of subjects achieving at least 10% reduction in weight at 52 weeks
52 weeks
Proportion of subjects achieving at least 10% reduction in weight compared with baseline
Time Frame: 24 weeks
Proportion of subjects achieving at least 10% reduction in weight at 24 weeks
24 weeks
Changes in body weight to calculate body mass index (BMI) at weeks 24 and 52 compared with baseline
Time Frame: 24 week and 52 week
Compare the change in weight to calculate the BMI among different treatment arms
24 week and 52 week
Changes in biochemical parameters
Time Frame: 24 week and 52 week
Changes in liver biochemistry, fasting glucose, fasting lipids, fasting insulin, HbA1C at weeks 24 and 52 compared with baseline
24 week and 52 week
A 30% decrease in insulin resistance at weeks 24 compared with baseline
Time Frame: week 24
A 30% decrease in insulin resistance at weeks 24 compared with baseline
week 24
Changes in liver stiffness to assess improvement of other metabolic disease weeks 24 compared with baseline
Time Frame: week 24
Changes in liver stiffness to assess improvement of other metabolic disease weeks 24 compared with baseline
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Siew Ng, Prof., Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2017

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

December 6, 2019

Study Registration Dates

First Submitted

April 7, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 13, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT-DM-RCT study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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