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Completed

NCT Number: NCT03452189

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

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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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vancomycin

Drug

Oral vancomycin 250mg capsules

Other names: vancomycin hydrochloride capsules

Placebo

Other

Placebo Pills distributed by Research Pharmacy labeled "placebo."

Primary outcomes

  1. Change in Plasma Concentration Measure of Indoxyl Sulphate (IS)

    Time frame: 4 weeks

    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

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

    Time frame: 4 weeks

    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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2018
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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