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

NYU Langone Health

Status and phase: Completed; Phase 2

Conditions: End Stage Renal Disease

Treatments: Drug: Vancomycin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03452189

17-00963

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

250mg of oral vancomycin First

Active Comparator group

Description:

After 3 months, initial experimental group will be switched to placebo for 3 months.

Treatment:

Drug: Vancomycin

Other: Placebo

Placebo First

Placebo Comparator group

Description:

After three months, the control group will be crossed over to weekly oral vancomycin (250mg)

Treatment:

Drug: Vancomycin

Other: Placebo