This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by Michael Silverman, Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Michael Silverman, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT02496390
First received: July 7, 2015
Last updated: June 14, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Diabetes Mellitus Non-alcoholic Fatty Liver Disease Biological: Autologous Biological: Allogeneic Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Michael Silverman, Lawson Health Research Institute:

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

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

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

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

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

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


Estimated Enrollment: 21
Study Start Date: June 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02496390

Contacts
Contact: Michael Silverman, MD 519 646 6311 ext 66311 Michael.Silverman@sjhc.london.on.ca
Contact: Seema Nair Parvathy, PhD 519 646 6311 ext 66311 SeemaNair.Parvathy@sjhc.london.on.ca

Locations
Canada, Ontario
Michael Silverman Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Seema Nair Parvathy, PhD    519 646 6311 ext 66311    InfectiousDiseases@sjhc.london.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Michael Silverman, MD Lawson Health Research Institute
  More Information

Publications:

Responsible Party: Michael Silverman, Chair of Infectious Diseases, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02496390     History of Changes
Other Study ID Numbers: IDFMT - 001
Study First Received: July 7, 2015
Last Updated: June 14, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Michael Silverman, Lawson Health Research Institute:
Fecal Microbial Transplantation
Gut microbiome
Metabolic disorders
Obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Digestive System Diseases

ClinicalTrials.gov processed this record on June 22, 2017