Phase 2
N=15
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT03452189 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Change in Plasma Concentration Measure of Indoxyl Sulphate (IS) — -25.31; 9.71 µM/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vancomycin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma Concentration Measure of Indoxyl Sulphate (IS) |
-25.31; 9.71 | — |
| PRIMARY Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS) |
-73.51; 0.64 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03452189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.