An Open-label Pilot Study of Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Proportion of at least 10% reduction in weight
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Fecal 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.
The therapy is generally well tolerated and appeared safe. No clinical studies have assessed the dosage of FMT in obese subjects.
Detailed Description
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. Fecal 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. Furthermore, clinical trials are being conducted to evaluate its use for other conditions including inflammatory bowel disease, irritable bowel syndrome, diabetes mellitus, non-alcoholic steatohepatitis and hepatic encephalopathy. 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 dosage of FMT in obese subjects.
Investigators
Siew Chien NG
Professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Age 18-75; and
- •BMI ≥28 kg/m\^2 and \< 45 kg/m\^2; and
- •Written informed consent obtained
Exclusion Criteria
- •Current pregnancy
- •Known history or concomitant significant gastrointestinal disorders (including Inflammatory Bowel Disease, current colorectal cancer)
- •Known history or concomitant significant food allergies
- •Immunosuppressed subjects
- •Known history of severe organ failure (including decompensated cirrhosis), kidney failure, epilepsy, acquired immunodeficiency syndrome
- •Current active sepsis
- •Known contraindications to oesophago-gastro-duodenoscopy (OGD)
- •Use of probiotic or antibiotics in recent 3 months
- •New drugs in the last three months that can impact on metabolism or body weight
- •Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, ileoectomy, colectomy
Outcomes
Primary Outcomes
Proportion of at least 10% reduction in weight
Time Frame: 6 weeks
Determine the proportion of at least 10% reduction in weight compared with baseline weight
Secondary Outcomes
- Decrease in waist to hip ratio and in total body weight(6,12, 26, 52, 78, 104 weeks)
- Proportion of subjects maintaining weight reduction(6,12, 26, 52, 78, 104 weeks)
- Changes in waist circumference(6,12, 26, 52, 78, 104 weeks)
- Change in biochemical parameters(6 weeks)