Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease

Jason Stubbs, MD

Status and phase

Withdrawn

Early Phase 1

Conditions

End Stage Renal Disease

Treatments

Drug: Rifaximin

Study type

Interventional

Funder types

Other

Identifiers

NCT02738905

STUDY00004204

Details and patient eligibility

About

The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide (TMAO) levels in patients with end-stage renal disease.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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