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NCT02124512 · ClinicalTrials.gov registry record · Phase 2
Blood Lipopolysaccharide (LPS) Rifaximin Study
A Phase 2 study, sponsored by Philip Kern.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT02124512: Completed Phase 2 study, sponsored by Philip Kern.
NCT02124512 is a Phase 2 study that has completed, run by Philip Kern. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02124512, a Phase 2 study, has completed, sponsored by Philip Kern.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
Metabolic syndrome is a condition involving elevated levels of fat in the blood, a tendency towards diabetes, hypertension, and too much fat around the abdomen (an increased waistline). Individuals with metabolic syndrome often have impaired glucose tolerance, which is a condition where blood sugar is normal when fasting (before eating), but is too high after drinking a sugary drink. This is due to an abnormality in the body's sensitivity to insulin (insulin resistance), which is due in part to an inability of the muscle to take up glucose. People with metabolic syndrome have inflammation in their fat tissue and in their blood stream, and the changes in the level of inflammatory chemicals produced by cells in your fat tissues will be studied. One possible source of the inflammation may be the bacteria in the intestine. When individuals eat fatty foods, some of the bacterial products become attached to the fat in their blood and then get directed to fat tissue. The investigators wish to determine whether individuals have an excessive amount of inflammation in their fat tissues, and whether this inflammation comes from the bacteria in their intestines. To determine this, the investigators wish to treat individuals with an antibiotic that reduces the bacteria in their intestines and in their blood, and determine whether this reduces their overall level of inflammation.
Primary Outcome
Plasma lipopolysaccharide (LPS) will be measured both in the fasting state and after a lipid-rich meal in obese subjects (Pre-Treatment: 0, 4 and 8 hr timepoints). The subjects will then be treated with the antibiotic rifaximin for 12 weeks to substantially reduce gut bacteria. LPS measurements at fasting and after a lipid-rich meal will be repeated (Post-Treatment: 0, 4 and 8 hr timepoints). The lipid tolerance tests before and after treatment with rifaximin will be assessed to determine whethe
Interventions
- OTHER Placebo
- DRUG Rifaximin SSD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-03 |
| Est. Completion | 2019-05-31 |
| Phase | Phase 2 |
What the finished NCT02124512 record still lists
NCT02124512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02124512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02124512 about?
NCT02124512 is a clinical study titled "Blood Lipopolysaccharide (LPS) Rifaximin Study". Metabolic syndrome is a condition involving elevated levels of fat in the blood, a tendency towards diabetes, hypertension, and too much fat around the abdomen (an increased waistline). Individuals with metabolic syndrome often have impaired glucose tolerance, which is a condition where blood sugar ...
What is the current status of trial NCT02124512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2015-03. Estimated completion is 2019-05-31.
What interventions are being tested in trial NCT02124512?
The interventions under investigation include: Placebo (OTHER), Rifaximin SSD (DRUG).
Who is sponsoring clinical trial NCT02124512?
This trial is sponsored by Philip Kern, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02124512's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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