CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 11 enrolled
Drug / intervention
Neomycin +1 moredrug
Likely dose
Neomycin 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01638429
NCT01638429Early Ph 1Completed

Methane Production and Glycemic Regulation in Pre-diabetic Subjects: Role of Methane in Glycemic Control

Cedars-Sinai Medical Center·interventional·Posted Jul 11, 2012·Updated May 2, 2019

In Brief

A Early Phase 1 clinical trial evaluating Neomycin and Rifaximin for Diabetes and Obesity. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this study is to determine how certain types of bacteria in the human gut may affect weight gain, and contribute to the development of diabetes. The investigators initial studies have shown that gut bacteria that produce methane may directly affect weight gain. These bacteria, called methanogens, produce methane gas as a byproduct, which can be detected through breath testing. Methane can slow the passage of food through the intestines, which would allow extra time for uptake and absorption of nutrients and calories, and might contribute to weight gain. The investigators have also found that people who have increased levels of methane-producing bacteria in their intestines also have higher levels of glucose in their blood. Therefore, control of how the body responds to insulin and uses glucose may be altered in methane-producing individuals. This research study is designed to test the investigational use of the drugs neomycin and rifaximin that have been approved by the U.S Food and Drug Administration (FDA). While neomycin is FDA-approved for treating skin infections, preparing the bowel for surgery, and hepatic encephalopathy (a condition that occurs when a damaged liver cannot remove the toxins that a healthy liver normally would), and rifaximin is FDA-approved for treating travelers' diarrhea, they are not yet approved to be used together for the treatment of methanogens or obesity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Obesity
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 11, 2012
Enrollment StartApr 1, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.0 years ago

Interventions

Neomycindrug

Neomycin: 500mg po bid for 10 days

Rifaximindrug

Rifaximin: 550mg po tid for 10 days