NCT03727321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

1.5 years

First QC Date

October 24, 2018

Last Update Submit

May 1, 2020

Conditions

ObesityMetabolic Syndrome

Keywords

Fecal microbial transplantobesitymetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (9)

  • Health-related quality of life (HRQL): EQ-5D Index

    12 week

  • Dietary Intake

    12 week

  • Inflammatory markers

    12 week

  • Stool Microbiome

    12 weeks

  • Anthropometric Measurements

    12 weeks

  • +4 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Cellulose

Fecal Microbial Transplant and cellulose

EXPERIMENTAL

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 TransplantDietary Supplement: Cellulose

Fiber

EXPERIMENTAL

Soluble corn fiber (PROMITOR®: Tate\&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS).

Dietary Supplement: Fiber

Fecal Microbial Transplant and Fiber

EXPERIMENTAL

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 TransplantDietary Supplement: Fiber

Interventions

Fecal Microbial TransplantCOMBINATION_PRODUCT

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
Fecal Microbial Transplant and FiberFecal Microbial Transplant and cellulose
FiberDIETARY_SUPPLEMENT

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)

Fecal Microbial Transplant and FiberFiber
CelluloseDIETARY_SUPPLEMENT

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

Fecal Microbial Transplant and cellulosePlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Interventions

Dietary FiberCellulose

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Karen Madsen, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

November 1, 2018

Study Start

July 1, 2018

Primary Completion

January 16, 2020

Study Completion

January 16, 2020

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

CA(2)