6416: Descriptive analysis of gut microbiome alterations in hyperoxaluric patients

Status: Recruiting

 

Background

Kidney stones affect as much as 10% of the US population with the most common type of stones made of calcium oxalate. Calcium and oxalate are present in the urine and can bind to each other, and form calcium oxalate kidney stones. Oxalate is absorbed in the gut from the food that is eaten and is removed from the body through urination. Gut bacteria is thought to play a role in decreasing oxalate absorption in the gut and its levels in the urine. With this research we hope to learn about differences in the bacteria that live in the gut of different groups of participants who are likely to form kidney stones, as well as healthy individuals. We will study healthy people with no history of kidney stones, people with a history of calcium oxalate (CaOx) kidney stones, people with a genetic disease called primary hyperoxaluria type1 (PH1) that increases their chances to form calcium oxalate kidney stones and, people with enteric hyperoxaluria (EH) a disease in which individuals have short bowels due to surgery which lead them to get calcium oxalate kidney stones.

The research questions are:

  1. How different is the gut bacteria between participants with the conditions that make them more likely to form kidney stones and healthy participants with no history of kidney stones?

  2. Is there any difference in the function of the individual bacteria, Oxalobacter formigenes known to reduce oxalate, between healthy participants with no history kidney stones and participants with PH1?

About this Study

This is a cross sectional study with 60 patients that will collect 2 fecal samples within one week. We will include:

  • 15  participants with healthy kidney function
  • 15 participants with CaOx kidney stone(s)
  • 15 participants with PH1
  • 15  participants with EH

Patients with kidney stone disease will be seen at Mayo Clinic, NYULMC and NY Harbor VA Medical Center. If the patients are seen outside of the study at one of our participating centers, we will look at their medical records so that we can collect information about their medical history, physical exam and the laboratory tests within 3 years of the beginning of the study. The stool specimens will be collected at home using kits provided by the medical center and shipped back to our NY Harbor VA Medical Center.

All patients will be asked to:

  • Fill out a food questionnaire
  • Collect 2 fecal samples

Targeted Enrollment

To be eligible for the interventional study (receive phosphorus), you must have ONE of the following:

  • A documented diagnosis of PH1, EH, CaOx kidney stone disease diagnosed within 5 years of the recruitment
  • Be a healthy adult with no medical disease

You are not eligible to participate if you:

  • Are less than 18 years old or older than 60 years of age
  • Have low kidney function (estimated GFR<50 ml/min/1.73 m2)
  • Have a kidney or liver transplant
  • Received antibiotic within 6 months of beginning the study

How to participate

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

United States

Minnesota

Mayo Clinic College of Medicine, Rochester
Contact: Julie Olson, Barb Seide and Alicia Meek
Phone: 800-270-4637
Phone: 507-255-0387|
E-mail: rarekidneystones@mayo.edu

New York

New York University, New York City
Contact: Lama Nazzal
Phone: 212-263-2922
E-mail: lama.nazzal@nyuumc.org