A Phase 2 interventional study of Fecal Microbial Transplant and Fiber in Obesity and Metabolic Syndrome, sponsored by University of Alberta. Completed at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by University of Alberta · Phase 2, Interventional, and Treatment
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.
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:
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)
Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients):
Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS):
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)
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 68 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
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Age ≥ 18 and \< 65 years at the time of screening
At least one of the following:
Exclusion Criteria:
Systolic blood pressure ≥180 or diastolic blood pressure ≥110 mmHg at screening.
Placebo: Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in foil packets.
Dietary Supplement: 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
Combination Product: Fecal Microbial Transplant · Dietary Supplement: Cellulose
Soluble corn fiber (PROMITOR®: Tate\&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS).
Dietary Supplement: 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).
Combination Product: Fecal Microbial Transplant · Dietary Supplement: Fiber
Fecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth.
Also known as: FMT
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)
Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in foil packets.
Insulin Sensitivity Assessment
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
Time frame: 12 weeks
Health-related quality of life (HRQL): EQ-5D Index
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).
Time frame: 12 week
Dietary Intake
Dietary intake will be assessed for each clinic using MyFitnessPal.
Time frame: 12 week
Inflammatory markers
. Levels of leptin, ghrelin, adiponectin, TNFα, IL-6, LPS (lipopolysaccharide), LPS-binding protein and zonulin will be determined using currently accepted laboratory techniques.
Time frame: 12 week
Stool Microbiome
Stool microbiome will be analyzed for Operational Taxonomic Unit determination.
Time frame: 12 weeks
Anthropometric Measurements
BMI (kg/m2)
Time frame: 12 weeks
Fasting lipid profile
Changes in Fasting lipid profile between baseline and 6 and 12 weeks
Time frame: 12 weeks
Glucose Tolerance Assessment
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.
Time frame: 12 weeks
Hunger and Satiety Assessment
Assessed via the standardized hunger and satiety questionnaire (categorical variables with no analog scale)
Time frame: 12 weeks
Gastrointestinal tolerance
Assessed via the standardized gastrointestinal tolerance questionnaire (categorical variables with no analog scale)
Time frame: 12 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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