Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
38 participants
INTERVENTIONAL
2015-06-30
2019-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Rifaximin
Participants will receive a 10-day course of Rifaximin.
Rifaximin
550mg pills
Placebo
Participants will receive a 10-day course of placebo.
Placebo
Placebo pill
Interventions
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Rifaximin
550mg pills
Placebo
Placebo pill
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability or unwillingness to provide consent
* Patients undergoing hemodialysis or peritoneal dialysis therapy or those who have undergone organ transplant
* Patients who may be pregnant
* Hemodynamically unstable patients
* Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease
* Patients with ongoing or recent infection and those with history of C-diff infection
* Patients with abnormal bowel structure secondary to surgical or anatomic variations
* Patients on certain medications including immunosuppressants, antidiarrheal agents, bile acid sequestrants and current or recent (within the last 3 months) use of antibiotics
18 Years
ALL
No
Sponsors
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Jason Stubbs, MD
OTHER
Responsible Party
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Jason Stubbs, MD
Associate Professor
Principal Investigators
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Jason Stubbs, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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References
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Kimber C, Zhang S, Johnson C, West RE 3rd, Prokopienko AJ, Mahnken JD, Yu AS, Hoofnagle AN, Ir D, Robertson CE, Miyazaki M, Chonchol M, Jovanovich A, Kestenbaum B, Frank DN, Nolin TD, Stubbs JR. Randomized, Placebo-Controlled Trial of Rifaximin Therapy for Lowering Gut-Derived Cardiovascular Toxins and Inflammation in CKD. Kidney360. 2020 Nov;1(11):1206-1216. doi: 10.34067/kid.0003942020. Epub 2020 Nov 25.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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STUDY00001638
Identifier Type: -
Identifier Source: org_study_id