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

NCT03452189 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 17-00963
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

250mg of oral vancomycin First

ACTIVE COMPARATOR

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

Drug: Vancomycin; Other: Placebo

Placebo First

PLACEBO COMPARATOR

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

Drug: Vancomycin; Other: Placebo

Interventions

Vancomycin DRUG

Oral vancomycin 250mg capsules

Also known as: vancomycin hydrochloride capsules

250mg of oral vancomycin First; Placebo First

Placebo OTHER

Placebo Pills distributed by Research Pharmacy labeled "placebo."

250mg of oral vancomycin First; Placebo First

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV graft.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Jerome Lowenstein
• Organization: NYU Langone Health

Jerome.Lowenstein@nyulangone.org

+1 212 263 5635

Study Officials

• Jerome Lowenstein, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized double-blinded placebo-controlled crossover study

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 2, 2018
• Study Start: November 27, 2017
• Primary Completion: August 18, 2018
• Study Completion: August 18, 2018
• Last Updated: March 26, 2021
• Results First Posted: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: The investigator who proposed to use the data.

Locations

US (1)