drugset / Trial / NCT03727321

FMT and Fiber in Patients With Metabolic Syndrome

NCT03727321

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-07-01
Primary completion
2020-01-16
Completion
2020-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Fecal Microbial Transplant Other / unclassified 50 g Oral