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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452189
• Other study ID #: 17-00963
• Status: Completed
• Phase: Phase 2
• Start date: November 27, 2017
• Est. completion date: August 18, 2018

Study information

• Verified date: March 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 18, 2018
• Est. primary completion date: August 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Vancomycin
Oral vancomycin 250mg capsules

Other:
• Placebo
Placebo Pills distributed by Research Pharmacy labeled "placebo."

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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