Back to resultsThe Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
250mg of oral vancomycin First
Placebo First
Arm Description
After 3 months, initial experimental group will be switched to placebo for 3 months.
After three months, the control group will be crossed over to weekly oral vancomycin (250mg)
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03452189
Brief Title
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
Official Title
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
August 18, 2018 (Actual)
Study Completion Date
August 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
randomized double-blinded placebo-controlled crossover study
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
250mg of oral vancomycin First
Arm Type
Active Comparator
Arm Description
After 3 months, initial experimental group will be switched to placebo for 3 months.
Arm Title
Placebo First
Arm Type
Placebo Comparator
Arm Description
After three months, the control group will be crossed over to weekly oral vancomycin (250mg)
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
vancomycin hydrochloride capsules
Intervention Description
Oral vancomycin 250mg capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Pills distributed by Research Pharmacy labeled "placebo."
Primary Outcome Measure Information:
Title
Change in Plasma Concentration Measure of Indoxyl Sulphate (IS)
Description
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
Time Frame
4 weeks
Title
Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS)
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome Lowenstein, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
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