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

February 10, 2022 updated by: Siew Chien NG, Chinese University of Hong Kong

An Open-label Pilot Study of Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12, 26, 52, 78, 104 weeks
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
6,12, 26, 52, 78, 104 weeks
Changes in waist circumference
Time Frame: 6,12, 26, 52, 78, 104 weeks
Changes in waist circumference compared with baseline
6,12, 26, 52, 78, 104 weeks
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
6,12, 26, 52, 78, 104 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Siew Ng, Prof., Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

December 27, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT-OB study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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