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

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: Vancomycin; Other: Placebo

• Registration Number: NCT03452189
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-27
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-02
• Primary Completion: 2018-08-18
• Study Completion: 2018-08-18
• Results First Submitted: 2020-10-22
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Results First Posted: 2021-03-26
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
250mg of oral vancomycin First	Placebo	After 3 months, initial experimental group will be switched to placebo for 3 months.
Placebo First	Placebo	After three months, the control group will be crossed over to weekly oral vancomycin (250mg)
250mg of oral vancomycin First	Vancomycin	After 3 months, initial experimental group will be switched to placebo for 3 months.
Placebo First	Vancomycin	After three months, the control group will be crossed over to weekly oral vancomycin (250mg)

Primary Outcome Measures

Name	Time	Method
Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS)	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
Change in Plasma Concentration Measure of Indoxyl Sulphate (IS)	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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States