Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fecal Microbial Transplantation and Fiber Supplementation in Participants With Obesity and Metabolic Syndrome.

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03477916
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
The Weston A. Price Foundation
Information provided by (Responsible Party):
Karen Madsen, University of Alberta

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date May 10, 2018
Actual Study Start Date  ICMJE April 9, 2018
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
insulin sensitivity [ Time Frame: Change between the time of screening and 6 weeks following treatment. ]
The primary endpoint is the change in insulin sensitivity between the time of screening and 6 weeks following treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03477916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
  • BMI [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    weight and height will be combined to report changes in BMI in kg/m^2 between baseline and 6 and 12 weeks
  • Waist to hip circumferences [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in waist to hip circumferences between baseline and 6 and 12 weeks
  • HbA1C [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes HbA1C between baseline and 6 and 12 weeks
  • fasting glucose [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes fasting glucose between baseline and 6 and 12 weeks
  • oral glucose tolerance [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in oral glucose tolerance between baseline and 6 and 12 weeks
  • Fasting lipid profile [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in Fasting lipid profile between baseline and 6 and 12 weeks
  • blood pressure [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in blood pressure between baseline and 6 and 12 weeks
  • EuroQol five dimensions questionnaire (EQ-5D™) [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in EuroQol five dimensions questionnaire scores to arrive at the participants quality of life between baseline and 6 and 12 weeks
  • SLIM Hunger and Satiety Questionnaire [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    The SLIM Hunger and satiety questionnaire scores used to arrive at the participants feelings of hunger and satiety. Changes in reported feelings of Hunger and Satiety between baseline and 6 and 12 weeks
  • serum levels of leptin, adiponectin, ghrelin, CRP, TNF-α, IL-6, LPS, and LPS-binding protein [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in serum levels of leptin, adiponectin, ghrelin, CRP, TNF-α, IL-6, LPS, and LPS-binding protein between baseline and 6 and 12 weeks
  • fecal microbiota composition [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in fecal microbiota composition between baseline and 6 and 12 weeks
  • stool short chain fatty acid composition [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in stool short chain fatty acid composition between baseline and 6 and 12 weeks
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 Microbial Transplantation and Fiber Supplementation in Participants With Obesity and Metabolic Syndrome.
Official Title  ICMJE Fecal Microbial Transplantation and Fiber Supplementation in Participants With Obesity and Metabolic Syndrome.
Brief Summary

Obesity is increasing in western society at a rapid rate and is associated with metabolic and cardiovascular disease. Although genetics, improper diet, and sedentary lifestyle are known to be factors that can cause obesity, there is a new idea that certain gut microbes may also be involved. Patients who are obese tend to have different kinds of gut microbes compared with lean healthy individuals. Previous studies have shown that changing the gut microbes of obese individuals by doing a fecal transplant (FMT) using gut microbes from a lean individual improves insulin resistance. However, the effects were not maintained. In addition, research has highlighted a necessary role for dietary fiber in the maintenance of microbes required for human health and also that increasing dietary fiber can reduce inflammation that is associated with insulin resistance. This project builds on the findings that gut microbes can be modulated by both FMT and dietary fiber supplementation and will examine if combining these two treatments can increase the effectiveness of these treatments.

The objective of this study is to use fecal microbial transplant to change the gut microbes of obese individuals to those seen in lean individuals and then to use fiber supplements to help maintain the beneficial effects. In this study, overweight individuals who have metabolic syndrome will receive a fecal transplant using a pill form and then consume a variety of fiber supplements for 6 weeks. Effects on metabolic parameters, quality of life, weight, and dietary intake will be followed. Microbial composition will be measured in stool samples.

Detailed Description

Phase: This is a phase II clinical trial.

Methodology: This is an exploratory, four-arm, parallel design, randomized placebo-controlled intervention study.

Study Duration: 12 weeks Study Center(s): This is a single center trial at the University of Alberta

Objectives:The objective of this study is to determine if fecal microbial transplantation (FMT) combined with supplementation with a combined fiber supplement of resistant starch type 4, acacia gum, and soluble corn fiber has a clinically significant effect on metabolic outcomes in obese subjects with metabolic syndrome

Primary Outcome: Changes in insulin sensitivity between the time of screening and 6 weeks following treatment.

Secondary Outcomes:

  • Changes in Body weight and anthropometric parameters between baseline and week 6.
  • Changes in HbA1C, fasting glucose, glucose tolerance test between baseline and week 6
  • Changes in fasting lipid profile between baseline and week 6
  • Changes in blood pressure between baseline and week 6
  • Quality of life and satiety between baseline and week 6
  • Changes in serum levels of leptin, adiponectin, ghrelin, CRP, TNF-α, IL-6, LPS, LPS-binding protein and zonulin between baseline and week 6
  • Changes in stool microbiota composition between baseline and week 6
  • Changes in stool short chain fatty acid composition between baseline and week 6

Number of Subjects: 68

Diagnosis and Main Inclusion Criteria

Primary Diagnosis:

• BMI > 30

Key Inclusion Criteria:

  • Age 18-64 years at screening
  • Total body weight fluctuation over the last 6 months <10%
  • Fasting plasma glucose > 5.6 mmol/L OR HgbA1c ≥6.5% (with or without taking an oral antidiabetic medication)
  • At least one of the following:

    • Fasting triglyceride ≥1.7 mmol/L (with or without taking a statin or fibrate)
    • HDL cholesterol <1.03 mmol/L in males or <1.29 mmol/L in females (with or without taking a statin or fibrate)
    • Known diagnosis of hypertension OR systolic blood pressure ≥130 or diastolic blood pressure ≥85 mmHg (with or without taking at least one antihypertensive agent).

Study Product, Dose, Route, Regimen FMT:

  • 50 gm of screened and encapsulated single donor stool (approximately 20-30 capsules) taken by mouth on day 1 of the trial after having fasted overnight and completed a bowel prep with Pico-Salax®.
  • Placebo pills will contain microcrystalline cellulose

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 gr by mouth daily from day 4 until trial completion.

Duration of administration:

FMT: Single dose of 50gm donor stool or placebo (microcrystalline cellulose) on day 1.

Fiber: Daily administration until completion at week 6

Reference therapy Both FMT and Fiber will be placebo matched as reference therapy.

Statistical Methodology: Study groups with by analyzed by pair-wise comparison with evaluation of means between and across groups using paired or unpaired t-tests for continuous outcomes and chi-squared tests for dichotomous ones. Multivariable predictors of change in relevant outcomes will be identified using appropriately constructed and calibrated linear regression models for continuous outcomes or logistic regression models for dichotomous ones.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Metabolic Syndrome
Intervention  ICMJE
  • Biological: FMT
    fecal microbial transplantation (FMT)
  • Biological: Placebo FMT
    Placebo fecal microbial transplantation (FMT)
  • Dietary Supplement: Prebiotic Fiber
    combined fiber supplement of resistant starch type 4, acacia gum, and soluble corn fiber
  • Dietary Supplement: Cellulose
    Cellulose
Study Arms  ICMJE
  • Control (Placebo FMT and cellulose)
    Interventions:
    • Biological: Placebo FMT
    • Dietary Supplement: Cellulose
  • Experimental: FMT only (FMT followed by cellulose)
    Interventions:
    • Biological: FMT
    • Dietary Supplement: Cellulose
  • Prebiotic only (Placebo FMT and prebiotic fiber)
    Interventions:
    • Biological: Placebo FMT
    • Dietary Supplement: Prebiotic Fiber
  • Experimental: FMT + prebiotic fiber
    Interventions:
    • Biological: FMT
    • Dietary Supplement: Prebiotic 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: March 19, 2018)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2020
Estimated Primary Completion Date April 1, 2020   (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 (FPG): 1) > 5.6 mmol/L OR Hemoglobin A1c ≥6.5% (with or without taking an oral antidiabetic medication).
    • At least one of the following criterion:

      1. Fasting triglyceride ≥1.7 (TG) mmol/L (with or without taking a statin or fibrate)
      2. HDL cholesterol <1.03 mmol/L in males or <1.29 mmol/L in females (with or without taking a statin or fibrate)
      3. Established diagnosis of hypertension OR SBP ≥130 or DBP ≥85 mmHg (with or without taking at least one antihypertensive agent).

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: Basmina Aminzadah, HBSc 7807354912 basmina@ualberta.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03477916
Other Study ID Numbers  ICMJE 00076642
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
Responsible Party Karen Madsen, 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 May 2018

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