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FMT and Fiber in Patients With Metabolic Syndrome (FMT)

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ClinicalTrials.gov Identifier: NCT03727321
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
The Weston A. Price Foundation
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE October 24, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date May 2, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
Insulin Sensitivity Assessment [ Time Frame: 12 weeks ]
The homeostasis Model Assessment-Insulin Resistance (HOMA-IR) is a mathematical model to predict the interaction between glucose and insulin dynamics across a range of glucose plasma levels assuming a feedback circuit between the liver and β-cells in the pancreas
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03727321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • Health-related quality of life (HRQL): EQ-5D Index [ Time Frame: 12 week ]
    Assessment of the current health related quality of life will be accomplished by conducting standardized interviews and by using the validated questionnaires EQ-5D Index. Participants will report perceived health outcomes using this validated survey, and rank overall perceived health from 0 (low)- 100 (high).
  • Dietary Intake [ Time Frame: 12 week ]
    Dietary intake will be assessed for each clinic using MyFitnessPal.
  • Inflammatory markers [ Time Frame: 12 week ]
    . Levels of leptin, ghrelin, adiponectin, TNFα, IL-6, LPS (lipopolysaccharide), LPS-binding protein and zonulin will be determined using currently accepted laboratory techniques.
  • Stool Microbiome [ Time Frame: 12 weeks ]
    Stool microbiome will be analyzed for Operational Taxonomic Unit determination.
  • Anthropometric Measurements [ Time Frame: 12 weeks ]
    BMI (kg/m2)
  • Fasting lipid profile [ Time Frame: 12 weeks ]
    Changes in Fasting lipid profile between baseline and 6 and 12 weeks
  • Glucose Tolerance Assessment [ Time Frame: 12 weeks ]
    The oral glucose tolerance test (OGTT) is a dynamic test that reflects the efficiency of the body to dispose of glucose after an oral load. It is commonly used in clinical scenarios to diagnose glucose intolerance and diabetes. [33] After overnight fast (> 8 h), blood samples for determination of glucose and insulin concentration will be taken at -5, 0, 30, 60, and 120 min following a standard oral glucose load.
  • Hunger and Satiety Assessment [ Time Frame: 12 weeks ]
    Assessed via the standardized hunger and satiety questionnaire (categorical variables with no analog scale)
  • Gastrointestinal tolerance [ Time Frame: 12 weeks ]
    Assessed via the standardized gastrointestinal tolerance questionnaire (categorical variables with no analog scale)
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 FMT and Fiber in Patients With Metabolic Syndrome
Official Title  ICMJE Fecal Microbial Transplantation and Fiber Supplementation in Subjects With Obesity and Metabolic Syndrome
Brief Summary

This study is looking at the safety and effectiveness of stool transplant, also known as Fecal Microbiota Transplantation (FMT) and prebiotic supplementation in the management of metabolic syndrome.

Metabolic syndrome is a common progressive medical condition that is linked to obesity, diabetes, and heart disease. Obesity and metabolic syndrome are associated with abnormalities in gut flora which lead to chronic inflammation. This chronic inflammation is thought to worsen the insulin resistance and heart disease seen with metabolic syndrome. Current treatment strategies have shown limited effect, are expensive, and have side effects with long-term use.

FMT is a one-time treatment that has been shown to replace the abnormal gut flora and improve metabolic disease by increasing anti-inflammatory short chain fatty acid (SCFA) production. However, the effects from FMT are not permanent. Prebiotic supplementation is one strategy that may help to extend the benefits of FMT by helping sustain high SCFA levels. At this point, it is not known how FMT and prebiotics work together to affect SCFA levels in participants with metabolic syndrome.

This study will look at this interaction and answer if prebiotic therapy is effective in prolonging the benefits of FMT in participants with metabolic syndrome.

Detailed Description

3.0 Design This is an exploratory four-arm, parallel design, randomized placebo-controlled intervention study in obese individuals with metabolic syndrome to evaluate whether FMT from lean donors combined with supplementation with prebiotic fiber will have a clinically significant effect on metabolic parameters. The study includes a 2-week screening/baseline period followed by a single FMT and a 6 week study period in which prebiotic fiber or placebo will be added in powdered form to the subject's normal diet for the duration of the trial (Appendix 1). A follow-up visit at 12 weeks will be done to determine if beneficial effects are maintained in the absence of ongoing fiber intake. A parallel arm design was chosen to avoid cross-over effects.

The four groups are:

  1. Control (Placebo FMT and cellulose)
  2. FMT only (FMT followed by cellulose)
  3. Prebiotic only (Placebo FMT and prebiotic fiber)
  4. FMT + prebiotic fiber Schedule and Procedures: Subjects will attend a total of 5 clinic appointments throughout the study for anthropometric and blood pressure measurements, dietary intake, hunger and satiety, and quality of life assessment using questionnaires, and for collection of blood and fecal samples (Appendix 2). The intervention will be stopped at 6 weeks. A final follow-up visit will occur at 12 weeks for anthropometric and blood pressure measurements, and collection of blood and stool samples.

3.1 Randomization Subjects will be randomized to one of 4 groups via computer-generated numbers and stratified by gender. Individuals will be blinded as to their group allocation to reduce bias. Randomization concealment will be protected by several levels of security, including our secure website, password protection by only those authorized to randomize and a variable blocked randomization.

3.2 Maintenance

Randomized codes will be maintained in REDCAP. Codes will be broken at the end of the trial.

3.3 Trial Treatment

Fecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth. These capsules will be frozen at -700C until date of administration on day 1 of the trial. The FMT will be given after individuals have fasted overnight and completes a bowel preparation using Pico-Salax®, a routine colonoscopy preparation. The study will use only one donor to reduce variability in donor profiles unless this donor becomes unavailable at which point backup donors will be available. Placebo FMT will consist of cellulose pills.

Fiber Supplementation:

Soluble corn fiber (PROMITOR®: Tate&Lyle)

  • Women: 4.5 gm of PROMITOR by mouth days 1-3 increased to 9 gm daily from day 4 until trial completion.
  • Men: 5.5 gm of PROMITOR by mouth days 1-3 increased to 11 gm by mouth daily from day 4 until trial completion.

Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients):

  • Women: 4.5 gm of powdered RS4 by mouth days 1-3 increased to 9 gm by mouth daily from day 4 until trial completion.
  • Men: 5.5gm of powdered RS4 by mouth days 1-3 increased to 11 gm by mouth daily from day 4 until trial completion.

Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS):

  • Women: 4.5 gm of powdered acacia gum by mouth days 1-3 increased to 9 gm by mouth daily from day 4 until trial completion.
  • Men: 5.5gm of powdered acacia gum by mouth days 1-3 increased to 11 gm by mouth daily from day 4 until trial completion.

The product will be supplied to patients on a weekly basis in pre-weighed foil packets.

Placebo: Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in identical foil packets.

3.4 Duration

The study duration is 12 weeks. Subjects will be seen in the clinic at recruitment, and then at 2 and 6 weeks following FMT. Intervention will be from 1-6 weeks. A final follow-up visit will occur at 12 weeks (Appendix 1)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Metabolic Syndrome
Intervention  ICMJE
  • Combination Product: Fecal Microbial Transplant
    Fecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth.
    Other Name: FMT
  • Dietary Supplement: Fiber
    A combination of soluble corn fiber (PROMITOR®: Tate&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), and Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS) for a total of 6 weeks (men 33g/day; women 27g/day)
  • Dietary Supplement: Cellulose
    Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in foil packets.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo: Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in foil packets.
    Intervention: Dietary Supplement: Cellulose
  • Experimental: Fecal Microbial Transplant and cellulose
    1. Fecal Microbial Transplant - Fecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth.
    2. Cellulose x 6weeks
    Interventions:
    • Combination Product: Fecal Microbial Transplant
    • Dietary Supplement: Cellulose
  • Experimental: Fiber
    Soluble corn fiber (PROMITOR®: Tate&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS).
    Intervention: Dietary Supplement: Fiber
  • Experimental: Fecal Microbial Transplant and Fiber
    1. Fecal Microbial Transplant
    2. Soluble corn fiber (PROMITOR®: Tate&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS).
    Interventions:
    • Combination Product: Fecal Microbial Transplant
    • Dietary Supplement: Fiber
Publications * Not Provided

*   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: October 30, 2018)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • Age ≥ 18 and < 65 years at the time of screening

    • BMI > 30
    • Total body weight fluctuation over the last 6 months less than 10%
    • Fasting plasma glucose > 5.6 mmol/L OR HgbA1c ≥5.5% OR patients receiving an antidiabetic medication
    • At least one of the following:

      • Fasting triglyceride ≥1.7 mmol/L OR receiving dyslipidemia medication
      • HDL cholesterol <1.03 mmol/L in males or <1.29 mmol/L in females OR receiving dyslipidemia medication
      • Known diagnosis of hypertension OR systolic blood pressure ≥130 or diastolic blood pressure ≥85 mmHg OR receiving antihypertension medication

Exclusion Criteria:

  • • Systolic blood pressure ≥180 or diastolic blood pressure ≥110 mmHg at screening.

    • Triglyceride ≥6 mmol/L.
    • Acute infectious or inflammatory condition over the presiding 4 weeks.
    • Current or recent use (Previous 6 months) of insulin for diabetes control.
    • History of oropharyngeal or significant esophageal dysphagia, inflammatory bowel disease, colon cancer, or colonic polyps with high grade dysplasia.
    • History of autoimmune conditions or chronic inflammatory condition, such as rheumatoid arthritis, chronic active hepatitis B or C, HIV, chronic pancreatitis, advanced NASH, or liver cirrhosis.
    • Active malignancy.
    • Active substance abuse or excessive EtOH (defined as >2 X 8oz drinks/d).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Valentin Mocanu, MD 7809097109 vmocanu1987@gmail.com
Contact: Karen Madsen, PhD 7804925257 kmadsen@ualberta.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03727321
Other Study ID Numbers  ICMJE Pro00076642
Has Data Monitoring Committee Yes
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
Plan to Share IPD: No
Plan Description: All individual participant data will be kept private and not distributed to other researchers outside of our study group. After the study is done, we will keep data stored for 25 years.
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE The Weston A. Price Foundation
Investigators  ICMJE
Principal Investigator: Karen Madsen, PhD University of Alberta
PRS Account University of Alberta
Verification Date March 2019

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