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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: Completed Early Phase 1 study, sponsored by Cedars-Sinai Medical Center.
NCT01638429 is a Early Phase 1 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 11 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of subjects who exhibited a decrease in breath methane levels to below detectable (below 3ppm) following antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment breath tests were performed within 2 weeks (14 days) of completing the course of antibiotics.
Interventions
- DRUG Rifaximin
- DRUG Neomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-04 |
| Phase | Early Phase 1 |
What the finished NCT01638429 record still lists
NCT01638429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Rifaximin is the first listed.
NCT01638429 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01638429's enrollment target sits among peer trials
11 1601st of 2000 higher than 373 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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