Clinical Trial: Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients
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.
Detailed Summary:
Kidney stones are a disease of worldwide prevalence with significant public health implications. About 60-80% of stones are composed of calcium oxalate (CaOx) for which high urinary oxalate, hyperoxaluria, is a major risk factor. Calcium and oxalate are components of the urine that can bind to each other, and form calcium oxalate kidney stones. Currently, the treatments and preventive measures of kidney stones are limited. Therefore, with this study, the investigators aim to learn about differences in the bacteria that live in the gut of people with diseases that lead to hyperoxaluria.
Hypothesis: The diversity and number of bacterial populations are different between individuals with conditions that predispose them to CaOx kidney stones formation and healthy individuals. The expression of genes involved in oxalate metabolism will be different in individuals predisposed with these conditions. At the strain level, the investigators expect a difference in the characteristics of the bacteria Oxalobacter formigenes (OxF) between healthy participants and patients with primary hyperoxaluria.
Study design: The investigators will collect 2 different stool samples within one week. The investigators will include participants in their study who are at risk of forming kidney stones. The investigators will include 1) healthy (non stone forming) participants, 2) patients with a history of calcium oxalate kidney stones, 3) patients with genetic diseases that predispose them to form calcium oxalate kidney stones and, 4) patients with fat malabsorption due to a bariatric surgical procedure (Roux-en Y gastric bypass; RYGB) that causes enteric hyperoxaluria and calcium oxalate kidney stones. The investigators will review the charts of the recruited patients with primary, enteric hyperoxaluria and idiopathic CaOx stones to collect their clini
Sponsor: VA New York Harbor Healthcare System
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: VA New York Harbor Healthcare System
Dates:
Date Received: May 25, 2016
Date Started: June 2016
Date Completion: June 2017
Last Updated: June 4, 2016
Last Verified: June 2016
