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Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients

NCT ID: NCT02794649

Last Updated: 2017-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-06-30

Brief Summary

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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 Description

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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?

Conditions

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Oxalate, Primary Hyperoxaluria, Microbiome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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healthy

Individuals without a history of kidney or bowel disease

No interventions assigned to this group

primary hyperoxaluria

Patients diagnosed with type I PH by genetic testing

No interventions assigned to this group

enteric hyperoxaluria

Patients with Roux-en-Y-gastric-bypass.

No interventions assigned to this group

calcium oxalate stone formers

History of passing or having surgically removed a calcium oxalate kidney stone within 5 years of recruitment.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

New York University

OTHER

Sponsor Role collaborator

VA New York Harbor Healthcare System

FED

Sponsor Role lead

Responsible Party

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Lama Nazzal

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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New York University School of Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lama Nazzal, MD

Role: CONTACT

[email protected]
212-686-7500 ext. 3877

Jessica Baylor, BA

Role: CONTACT

[email protected]
646-501-4159

Facility Contacts

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Lama Nazzal, MD

Role: primary

[email protected]

Jessica Baylor, BA

Role: backup

[email protected]

Other Identifiers

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RKSC6416

Identifier Type: -

Identifier Source: org_study_id