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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: Vancomycin; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 250mg of oral vancomycin First; After 3 months, initial experimental group will be switched to placebo for 3 months.	Drug: Vancomycin; Oral vancomycin 250mg capsules; Other Names: vancomycin hydrochloride capsules; Other: Placebo; Placebo Pills distributed by Research Pharmacy labeled "placebo."
PLACEBO_COMPARATOR: Placebo First; After three months, the control group will be crossed over to weekly oral vancomycin (250mg)	Drug: Vancomycin; Oral vancomycin 250mg capsules; Other Names: vancomycin hydrochloride capsules; Other: Placebo; Placebo Pills distributed by Research Pharmacy labeled "placebo."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	4 weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jerome Lowenstein, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2017
• Primary Completion (ACTUAL): August 18, 2018
• Study Completion (ACTUAL): August 18, 2018

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (ACTUAL): March 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 17-00963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No