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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2018-08-18

Brief Summary

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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.

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Infection

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized double-blinded placebo-controlled crossover study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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250mg of oral vancomycin First

After 3 months, initial experimental group will be switched to placebo for 3 months.

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Oral vancomycin 250mg capsules

Placebo

Intervention Type OTHER

Placebo Pills distributed by Research Pharmacy labeled "placebo."

Placebo First

After three months, the control group will be crossed over to weekly oral vancomycin (250mg)

Group Type PLACEBO_COMPARATOR

Vancomycin

Intervention Type DRUG

Oral vancomycin 250mg capsules

Placebo

Intervention Type OTHER

Placebo Pills distributed by Research Pharmacy labeled "placebo."

Interventions

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Vancomycin

Oral vancomycin 250mg capsules

Intervention Type DRUG

Placebo

Placebo Pills distributed by Research Pharmacy labeled "placebo."

Intervention Type OTHER

Other Intervention Names

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vancomycin hydrochloride capsules

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No