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Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789461
Recruitment Status : Active, not recruiting
First Posted : December 28, 2018
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obesity Procedure: Fecal Microbiota Transplantation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Pilot Study of Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fecal Microbiota Transplantation
FMT infusion
 Procedure: Fecal Microbiota Transplantation
FMT infusion (100-200ml) and Mucosal Microbiota Assessment (To assess the fecal and mucosal microbiota before and after FMT)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Proportion of subjects maintaining weight reduction [ Time Frame: 12, 26, 52, 78, 104 weeks ]
    Proportion of subjects maintaining at least 10% reduction in weight compared with baseline

  2. Proportion of subjects maintaining weight reduction [ Time Frame: 6,12, 26, 52, 78, 104 weeks ]
    Proportion of subjects maintaining at least 5% reduction in weight compared with baseline

  3. Changes in waist circumference [ Time Frame: 6,12, 26, 52, 78, 104 weeks ]
    Changes in waist circumference compared with baseline

  4. Decrease in waist to hip ratio and in total body weight [ Time Frame: 6,12, 26, 52, 78, 104 weeks ]
    At least 5% decrease in waist to hip ratio and in total body weight

  5. Change in biochemical parameters [ Time Frame: 6 weeks ]
    Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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): NCT03789461


Locations
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Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong
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:

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Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03789461    
Other Study ID Numbers: FMT-OB study
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: February 2022

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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 Transplantation
FMT
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight