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Interventional Bioremediation of Microbiota in Metabolic Syndrome

NCT02730962 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-02-22

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Alexander Khoruts, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730962 on ClinicalTrials.gov