The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome

NYU Langone Health15 enrolled

Overview

The purpose of this study is to determine if multiple doses of vancomycin over the course of 3 months will perturb the intestinal flora (microbiome) and result in reduced serum concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the study will permit investigators to assess the variability of serum uremic retention solute concentrations with and without antibiotic over a three-month period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

End Stage Renal Disease

Interventions

VancomycinDRUG

Oral vancomycin 250mg capsules

PlaceboOTHER

Placebo Pills distributed by Research Pharmacy labeled "placebo."

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV graft. Exclusion Criteria: * Antibiotics received within the last 3 months; * recent diarrhea * known allergy to vancomycin * history of C. difficile infection * elevation of white blood cell count or fever within one week of enrollment.

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Change in Plasma Concentration Measure of Indoxyl Sulphate (IS)

Plasma concentrations of IS were measured by HPLC (high pressure liquid chromatography). Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported

Time frame: 4 weeks

Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS)

Plasma concentrations of P-Cresyl Sulphate (PCS) were measured by HPLC (high pressure liquid chromatography) Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported

Time frame: 4 weeks

Data from ClinicalTrials.gov

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