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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-02-26

Brief Summary

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

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Detailed Description

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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.

Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rifaximin

Participants will receive study drug for a period of 7 days.

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

One 550 mg tablet taken orally two times a day.

Interventions

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Rifaximin

One 550 mg tablet taken orally two times a day.

Intervention Type DRUG

Other Intervention Names

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XIFAXAN

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No