FMT and Fiber in Patients With Metabolic Syndrome

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.

Conditions

• Obesity
• Metabolic Syndrome

Interventions

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.

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.

Sponsors & Collaborators

• The Weston A. Price Foundation

  collaborator OTHER

• University of Alberta

  lead OTHER

Principal Investigators

• Karen Madsen, PhD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-01

Primary Completion

2020-01-16

Completion

2020-01-16

Countries

• Canada

Study Locations