Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients

NCT02794649 | Unknown DMC

• 1 other identifier: RKSC6416
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxalate, Primary Hyperoxaluria, Microbiome

Outcome Measures

Primary Outcomes (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.

  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.

  1 year

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA New York Harbor Healthcare System: lead
• Mayo Clinic: collaborator
• New York University: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

fecal samples

MeSH Terms

Conditions

Hyperoxaluria, Primary

Condition Hierarchy (Ancestors)

Hyperoxaluria; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Lama Nazzal, MD

CONTACT

212-686-7500; lama.nazzal@nyumc.org

Jessica Baylor, BA

CONTACT

646-501-4159; jessica.baylor@nyumc.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 9, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

US (1)