Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease
- Registration Number
- NCT02738905
- Lead Sponsor
- Jason Stubbs, MD
- Brief Summary
The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide (TMAO) levels in patients with end-stage renal disease.
- Detailed Description
Study participants will undergo 3 study visits: baseline, day 7 (immediately post-therapy), day 21 (2 weeks post-therapy). All participants will provide blood and stool samples at each visit.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Diagnosis of end-stage renal disease
- Receiving chronic intermittent hemodialysis
Exclusion Criteria
- Patients with less advanced kidney disease
- Inability or unwillingness to provide informed consent
- 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, or recent (within the last 2 months) use of antibiotics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rifaximin Rifaximin Participants will receive study drug for a period of 7 days.
- Primary Outcome Measures
Name Time Method Change in serum TMAO levels Change from Baseline to Day 7
- Secondary Outcome Measures
Name Time Method Change in fecal bacterial species Change from Baseline to Day 21 Change in serum TMAO levels Change from Baseline to Day 21 Change in fecal bacterial colony numbers Change from Baseline to Day 21
Trial Locations
- Locations (2)
Westwood Dialysis Center
🇺🇸Westwood, Kansas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States