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Transplantation of Microbes for Treatment of Metabolic Syndrome & NAFLD (FMT)

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: NCT02496390
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
Non-alcoholic fatty liver disease (NAFLD) occurs when excess fat is deposited in the liver. Almost all patients also have obesity and insulin resistance (the inability of the body to effectively use insulin). Obesity and NAFLD are intricately intertwined and are increasing in incidence. While weight loss is the most effective therapy for NAFLD, the investigators' efforts are failing and in the next generation it will become the most common cause of liver failure in Canada. Recently, researchers have focused on the potential use of altering the composition of bacteria in the gut (microbiome) to alter absorption of energy from food, deposition of fat and resistance to insulin. This study will determine if transplantation of bacteria from the stool of a healthy volunteer into an individual with metabolic syndrome and NAFLD (i.e. fecal microbiota transplant/FMT) can alter insulin resistance and reduce the amount of fat deposited in the liver. FMT is being studied to treat several clinical conditions and is now standard of care for the treatment of refractory Clostridium difficile infection. Investigators are proposing a randomized controlled pilot study of FMT in 21 patients to determine the feasibility and to inform us of changes needed for a larger study.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Non-alcoholic Fatty Liver Disease Biological: Autologous Biological: Allogeneic Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transplantation of Microbes of Fecal Origin for Prevention and Treatment of Metabolic Syndrome and Non Alcoholic Fatty Liver Disease
Actual Study Start Date : June 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : December 2018


Arm Intervention/treatment
Placebo Comparator: Autologous

Patients will be randomized to receive a fecal transplant using their own microbes/Feces (autologous - 9 patients).

Dosage - approx 100ml fecal sample, one time, procedure duration ~1hr

Biological: Autologous
Patients will have their normal microbiome reduced using an oral preparation (pico-salax) as used for routine colonic preparation for colonoscopy. • Administration of the FMT will be via a nasoduodenal tube inserted at the time of gastroscopy. Dosage - approx 100ml previously frozen fecal sample obtained from the patient prior to colonic preparation.
Other Name: Autologous fecal infusions

Active Comparator: Allogenic

Patients will be randomized to receive a fecal transplant of feces/microbiome from the healthy donor (allogeneic - 12 patients).

Dosage - approx 100ml fecal sample, one time, procedure duration ~1hr

Biological: Allogeneic
Patients will have their normal microbiome reduced using an oral preparation (pico-salax) as used for routine colonic preparation for colonoscopy. • Administration of the FMT will be via a nasoduodenal tube inserted at the time of gastroscopy. Dosage - approx 100ml previously frozen fecal sample obtained from a lean donor prior to colonic preparation.
Other Name: Fecal Microbial Transplantation




Primary Outcome Measures :
  1. Improvement in Homeostasis model assessment [HOMA] score. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Fat reduction [ Time Frame: 6 months ]
    Percentage of fat in liver Magnetic Resonance Imaging [MRI]

  2. Reducing body fat [ Time Frame: 6 months ]
    Change in waist circumference and weight

  3. Gut permeability [ Time Frame: 6 months ]
    Change in percentage lactulose absorption

  4. Microbiome modulation [ Time Frame: 6 months ]
    Change in microbiome of stool and duration of change before reverting to baseline

  5. Modulation of lipid and hormone metabolism [ Time Frame: 6 months ]
    Change in markers of lipid metabolism and hormones associated with adiposity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Gender: Male: only male participants are being studied
  • Age limits: Minimum - 18yrs and above and Maximum-NA
  • Eligibility Criteria: Participants who meet the criteria's mentioned below will only be selected for the study
  • Inclusion Criteria:
  • Attendance at the gastroenterology/hepatology clinic with a diagnosis of NAFLD as well as metabolic syndrome.
  • Ability to provide informed Consent.
  • Exclusion Criteria:
  • Type 1 or 2 Diabetes requiring ongoing hypoglycemic medications.
  • Inability to attend follow-up visits.
  • Inability to provide informed written consent.
  • Ongoing use of antibiotics or probiotics.
  • Previous or planned bariatric surgery.
  • Presence of a chronic intestinal disease e.g. Celiac, malabsorption, Colonic tumor.
  • Immunosuppression from transplantation, HIV, Cancer chemotherapy or ongoing use of any immunosupressive agents.
  • Pregnant women
  • Any contra-indications for MRI as listed below: a. Previous brain surgery (using the language outlined in the Health Sciences Research Ethics Board [HSREB] Guideline, section 2-G-004) Pacemaker, Cerebral aneurism clips, neurostimulator, Metallic heart valves, Intra Uterine Devices [IUD], Joint replacement, Metal plates Bone or joint pins, Venacava filters, Embolization coils, Cochlear implants, Greenfield Filter, Seizures, Claustrophobia, Bullet/gunshot wound, Non-removable prosthesis, Non-removable artificial limbs, Surgical clips, Metal screws or pins, Shrapnel/metallic fragments, Harrington rod, Insulin pump, Ever had metal removed from in or around the eye, Ever been a metal worker (i.e. welder, machinist), Non-removable hearing aids, Bird nest or Gianturco filter, Metal braces, Severe heart disease (including susceptibility to arrhythmias), Weight or body habitus that will prevent a successful MRI study.

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): NCT02496390


Locations
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Canada, Ontario
Michael Silverman
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Michael Silverman, MD Lawson Health Research Institute
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02496390    
Other Study ID Numbers: IDFMT - 001
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lawson Health Research Institute:
Fecal Microbial Transplantation
Gut microbiome
Metabolic disorders
Obesity
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases