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

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ClinicalTrials.gov Identifier: NCT03789461
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE December 24, 2018
First Posted Date  ICMJE December 28, 2018
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE December 28, 2018
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03789461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
  • 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
  • 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
  • Changes in waist circumference [ Time Frame: 6,12, 26, 52, 78, 104 weeks ]
    Changes in waist circumference compared with baseline
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects
Official Title  ICMJE An Open-label Pilot Study of Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Procedure: Fecal Microbiota Transplantation
FMT infusion (100-200ml) and Mucosal Microbiota Assessment (To assess the fecal and mucosal microbiota before and after FMT)
Study Arms  ICMJE Experimental: Fecal Microbiota Transplantation
FMT infusion
Intervention: Procedure: Fecal Microbiota Transplantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amy LI +852 26373225 amyli@cuhk.edu.hk
Contact: Kitty Cheung +852 26373260 kittyccy@cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03789461
Other Study ID Numbers  ICMJE FMT-OB study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Siew Chien NG, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Siew NG, Prof. Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP