NCT02730962

Interventional Bioremediation of Microbiota in Metabolic Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether changing the microbial composition in the colon can improve metabolism of sugar in people who are on the verge of developing diabetes (pre-diabetics). Study participants will undergo a fecal microbiota transplantation (FMT) using material from lean donors, as well as a series of tests prior to and after the transplant. The investigators will examine any changes in fecal bacterial composition associated with FMT and determine if any observed changes have an influence on blood sugar metabolism.

Conditions

• Pre-Diabetes

Interventions

Type	Name	Description
DRUG	Vancomycin	Vancomycin 3 times a day for 7 days
OTHER	Placebo	Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic
DRUG	Neomycin	Neomycin 3 times a day for 1 day
DRUG	Clindamycin	Clindamycin 3 times a day for 5 days
PROCEDURE	Fecal Microbiota Transplantation	FMT conducted via colonoscopy

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-04-07
• Last updated: 2023-02-22
• Results posted: 2020-11-20

Locations

1 site across 1 country: United States