End Stage Renal Disease
Conditions
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.
Interventions
DRUGRifaximin
One 550 mg tablet taken orally two times a day.
Sponsors
American Heart Association
Jason Stubbs, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum TMAO levels | Change from Baseline to Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum TMAO levels | Change from Baseline to Day 21 |
| Change in fecal bacterial species | Change from Baseline to Day 7 |
| Change in fecal bacterial colony numbers | Change from Baseline to Day 7 |
Countries
United States
Outcome results
None listed