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NCT01638429 · ClinicalTrials.gov registry record · Early Phase 1

Role of Methane in Glycemic Control

A Early Phase 1 study, sponsored by Cedars-Sinai Medical Center.

Completed
Registry status
Early Phase 1
Development phase
11
Enrollment target

NCT01638429 is a Early Phase 1 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 11 participants.

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The verdict

NCT01638429, a Early Phase 1 study, has completed, sponsored by Cedars-Sinai Medical Center.

COMPLETED
Registry status
Early Phase 1
Development phase
11 participants
Enrollment target

Study 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.

Interventions

  • DRUG Rifaximin
  • DRUG Neomycin

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2012-04
Est. Completion 2014-04
Phase Early Phase 1

Sponsor

Cedars-Sinai Medical Center

339 total trials

What the Registry Record Tells You About NCT01638429

The ClinicalTrials.gov registry entry for NCT01638429 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Rifaximin is the first listed.

NCT01638429 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01638429 about?

NCT01638429 is a clinical study titled "Role of Methane in Glycemic Control". 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...

What is the current status of trial NCT01638429?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2012-04. Estimated completion is 2014-04.

What interventions are being tested in trial NCT01638429?

The interventions under investigation include: Rifaximin (DRUG), Neomycin (DRUG).

Who is sponsoring clinical trial NCT01638429?

This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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