Randomised Placebo-controlled Study of FMT to Impact Body Weight and Glycemic Control in Obese Subjects With T2DM
Condition: Type2 Diabetes; Type 2 Diabetes Mellitus; Obese
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight
Study type: Interventional

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.
    

Intervention name(s): Fecal Microbiota Transplantation; Lifestyle Modification Program; Sham
Intervention type(s): Procedure; Behavioral; Procedure
Intervention description(s): FMT; Lifestyle; Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fecal Microbiota Transplant