Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients
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|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
|Condition or disease|
|Oxalate, Primary Hyperoxaluria, Microbiome|
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:
- 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?
- 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?
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
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.
calcium oxalate stone formers
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. [ 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
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
|Contact: Lama Nazzal, MD||212-686-7500 ext firstname.lastname@example.org|
|Contact: Jessica Baylor, BAemail@example.com|