An observational study in Oxalate, Primary Hyperoxaluria, Microbiome, sponsored by VA New York Harbor Healthcare System. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-26.
Sponsored by VA New York Harbor Healthcare System · Observational
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.
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:
42 studies on the registry are indexed under Hyperoxaluria, Primary; 11 are open to participants now.
This study's planned enrollment of 60 is below the median of 730 across 13 observational studies indexed under Hyperoxaluria, Primary.
Browse Hyperoxaluria, Primary studies →VA New York Harbor Healthcare System is the lead sponsor of 15 studies on the registry; none are open to participants now.
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This is a cross sectional study with 60 patients that will collect 2 fecal samples within one week. We will include:
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Exclusion Criteria:
Individuals without a history of kidney or bowel disease
Patients diagnosed with type I PH by genetic testing
Patients with Roux-en-Y-gastric-bypass.
History of passing or having surgically removed a calcium oxalate kidney stone within 5 years of recruitment.
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.
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.
Time frame: 1 year
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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VA New York Harbor Healthcare System