Clinical trial NCT03789461: Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects
Official title: An Open-label Pilot Study of Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Fecal Microbiota Transplantation
FMT
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-75; and
2. BMI ≥28 kg/m\^2 and \< 45 kg/m\^2; and
3. Written informed consent obtained

Exclusion Criteria:

1. Current pregnancy
2. Known history or concomitant significant gastrointestinal disorders (including Inflammatory Bowel Disease, current colorectal cancer)
3. Known history or concomitant significant food allergies
4. Immunosuppressed subjects
5. Known history of severe organ failure (including decompensated cirrhosis), kidney failure, epilepsy, acquired immunodeficiency syndrome
6. Current active sepsis
7. Known contraindications to oesophago-gastro-duodenoscopy (OGD)
8. Use of probiotic or antibiotics in recent 3 months
9. New drugs in the last three months that can impact on metabolism or body weight
10. Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, ileoectomy, colectomy
11. Patients who have a confirmed current active malignancy or cancer

Primary outcomes:
measure: Proportion of at least 10% reduction in weight
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of subjects maintaining weight reduction
timeFrame: 12, 26, 52, 78, 104 weeks
measure: Proportion of subjects maintaining weight reduction
timeFrame: 6,12, 26, 52, 78, 104 weeks
measure: Changes in waist circumference
timeFrame: 6,12, 26, 52, 78, 104 weeks
measure: Decrease in waist to hip ratio and in total body weight
timeFrame: 6,12, 26, 52, 78, 104 weeks
measure: Change in biochemical parameters
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Siew NG, Prof.
role: PRINCIPAL_INVESTIGATOR
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