Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794649
Recruitment Status : Unknown
Verified September 2017 by Lama Nazzal, VA New York Harbor Healthcare System.
Recruitment status was:  Recruiting
First Posted : June 9, 2016
Last Update Posted : September 26, 2017
Sponsor:
Collaborators:
Mayo Clinic
New York University
Information provided by (Responsible Party):
Lama Nazzal, VA New York Harbor Healthcare System

Brief Summary:
To characterize the microbiome in 4 groups of subjects (primary hyperoxaluria type I (PH1), idiopathic CaOx stone, enteric hyperoxaluria (EH) and healthy participants) by comparing the number of species and diversity of the microbial populations and pathway for oxalate metabolism by paralleling the gene expression of enzymes involved in oxalate degradation by gut bacteria.

Condition or disease
Oxalate, Primary Hyperoxaluria, Microbiome

Detailed Description:

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.

Our 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?

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Group/Cohort
healthy
Individuals without a history of kidney or bowel disease
primary hyperoxaluria
Patients diagnosed with type I PH by genetic testing
enteric hyperoxaluria
Patients with Roux-en-Y-gastric-bypass.
calcium oxalate stone formers
History of passing or having surgically removed a calcium oxalate kidney stone within 5 years of recruitment.



Primary Outcome Measures :
  1. Differences in composition of the fecal microbiome as measured by 16S ribosomal ribonucleic acid (rRNA) sequencing and whole genome shotgun sequencing between the study groups. [ Time Frame: 1 year ]
    Diversity and abundance of operational taxonomic units (OTUs) between different groups of subjects will be tested. Data from shotgun sequencing and degenerate quantitative polymerase chain reactions (qPCRs) will yield comparative expressions of the oxalate metabolism genes between the groups.


Biospecimen Retention:   Samples Without DNA
fecal samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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 Calcium Oxalate kidney stone(s)
  • 15 participants with Primary Hyperoxaluria type I
  • 15 participants with Enteric Hyperoxaluria
Criteria

Inclusion Criteria:

  • Primary hyperoxaluria: Patients diagnosed with type I PH by genetic testing and part of the Rare Kidney Stone Consortium (RKSC) Primary hyperoxaluria registry
  • Enteric hyperoxaluria: Patients with Roux-en-Y-gastric-bypass
  • Idiopathic CaOx stone : History of passing or having surgically removed a calcium oxalate kidney stone within 5 years of recruitment
  • Healthy participants with no history of kidney or bowel disease

Exclusion Criteria:

  • History of kidney or liver transplant
  • History of antibiotics use within 6 months of recruitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794649


Contacts
Layout table for location contacts
Contact: Lama Nazzal, MD 212-686-7500 ext 3877 lama.nazzal@nyumc.org
Contact: Jessica Baylor, BA 646-501-4159 jessica.baylor@nyumc.org

Locations
Layout table for location information
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Lama Nazzal, MD       lama.nazzal@nyumc.org   
Contact: Jessica Baylor, BA       jessica.baylor@nyumc.org   
Sponsors and Collaborators
VA New York Harbor Healthcare System
Mayo Clinic
New York University
Layout table for additonal information
Responsible Party: Lama Nazzal, MD, MSc, VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier: NCT02794649    
Other Study ID Numbers: RKSC6416
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperoxaluria, Primary
Hyperoxaluria
Kidney Diseases
Urologic Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases