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

NCT ID: NCT03127696

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-26
• Study Completion Date: 2019-12-06

Brief 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.

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.

Conditions

Type2 Diabetes; Type 2 Diabetes Mellitus; Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FMT + LMP

FMT and lifestyle modification program

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: PROCEDURE

FMT

Lifestyle Modification Program

Intervention Type: BEHAVIORAL

Lifestyle

FMT alone

Fecal Microbiota Transplantation

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: PROCEDURE

FMT

Sham + LMP

Sham and lifestyle modification program

Group Type: SHAM_COMPARATOR

Lifestyle Modification Program

Intervention Type: BEHAVIORAL

Lifestyle

Sham

Intervention Type: PROCEDURE

Sham

Interventions

Fecal Microbiota Transplantation

FMT

Intervention Type: PROCEDURE

Lifestyle Modification Program

Lifestyle

Intervention Type: BEHAVIORAL

Sham

Sham

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Siew Chien NG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siew NG, Prof.

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

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Other Identifiers

FMT-DM-RCT study

Identifier Type: -

Identifier Source: org_study_id