NCT03452189

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

Completed Phase 2 Results posted Last updated 26 March 2021

What this trial tests

Phase 2 trial testing Vancomycin in End Stage Renal Disease in 15 participants. Completed in 18 August 2018.

Timeline

27 November 2017

Primary endpoint
18 August 2018

18 August 2018

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	15
Start date	27 November 2017
Primary completion	18 August 2018
Estimated completion	18 August 2018
Sites	1 location across United States

Drugs / interventions tested

• Vancomycin (vancomycin) — full drug profile →
• Placebo

Conditions studied

• End Stage Renal Disease — all drugs for End Stage Renal Disease →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 80, any sex, with End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Plasma Concentration Measure of Indoxyl Sulphate (IS) Primary · 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

Group	Value	95% CI
250mg of Oral Vancomycin First, Then Placebo	-25.31	± 36.3
Placebo First, Then 250mg of Oral Vancomycin	9.71	± 49.80

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

Group	Value	95% CI
250mg of Oral Vancomycin First, Then Placebo	-73.51	± 127.00
Placebo First, Then 250mg of Oral Vancomycin	0.64	± 79.50

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.