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

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ClinicalTrials.gov Identifier: NCT03127696
Recruitment Status : Active, not recruiting
First Posted : April 25, 2017
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Type 2 Diabetes Mellitus Obese Procedure: Fecal Microbiota Transplantation Behavioral: Lifestyle Modification Program Procedure: Sham Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 26, 2017
Actual Primary Completion Date : December 5, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Explore changes in fungome microbiota [ Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52 ]
    Explore changes in fungome microbiota

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127696


Locations
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Hong Kong
The Chinese University of Hong Kong
Sha Tin, Hong Kong, 000000
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Siew NG, Prof. Chinese University of Hong Kong
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03127696    
Other Study ID Numbers: FMT-DM-RCT study
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Siew Chien NG, Chinese University of Hong Kong:
Fecal Microbiota Transplant
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases