Oxalate, Primary Hyperoxaluria, MicrobiomeNCT02794649
Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients
An observational study of Oxalate, Primary Hyperoxaluria, Microbiome, run by VA New York Harbor Healthcare System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxalate, Primary Hyperoxaluria, Microbiome
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- History of kidney or liver transplant
- History of antibiotics use within 6 months of recruitment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York University School of Medicine
New York, New York, 10016
Lama Nazzal, MD, lama.nazzal@nyumc.org
Jessica Baylor, BA, jessica.baylor@nyumc.org
About this study
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.
Read the detailed description
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?
- Medical subject headings
- Hyperoxaluria, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxalate, Primary Hyperoxaluria, MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA New York Harbor Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Mayo Clinic, New York University
- Responsible party
- Principal investigator, Lama Nazzal, VA New York Harbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794649
- Sponsor's protocol ID
- RKSC6416
- Status last verified
- Sep 2017
- First submitted
- 25 May 2016
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients
- ClinicalTrials.gov ID
- NCT02794649
- Acronym / sponsor ID
- RKSC6416
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Collaborators
- Mayo Clinic, New York University
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- History of kidney or liver transplant
- History of antibiotics use within 6 months of recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxalate, Primary Hyperoxaluria, Microbiome, run by VA New York Harbor Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lama Nazzal, MD (212-686-7500 ext. 3877, lama.nazzal@nyumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.