Enteric HyperoxaluriaNCT05124886
Gut Kidney Axis in Enteric Hyperoxaluria
A study testing Moderately High Oxalate (MOx) Diet in people with Enteric Hyperoxaluria, run by NYU Langone Health at 1 site in United States.
Trial summary
40 subjects with a confirmed diagnosis of IBD or >6 months post-RYGB with a diagnosed USD event or kidney stone on imaging within the past three years and 40 healthy controls will be administered a high oxalate diet on Days 0-3 and Days 21-24 with a washout period on Days 4-7 and will be administered 250mg sodium… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Enteric Hyperoxaluria
- What is being tested?
- Moderately High Oxalate (MOx) Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Subjects > 18 years and < 80 years of age
- a confirmed diagnosis of IBD or > 6 months post- RYGB, with a diagnosis USD event (renal colic with spontaneous stone passage, emergency room visits, or urological interventions) or have kidney stone on imaging (CT, MRI, or US) in the previous three years.
- We will include all racial and ethnic groups, and both men and women.
- In order to be eligible in this study as a healthy control, an individual must meet all of the following criteria:
- Subjects > 18 years and < 80 years of age
- Healthy controls with no chronic diseases, not on any chronic medications, no history of GI pathology, or urinary stone disease (USD).
- We will include all racial and ethnic groups, and both men and women.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- pregnant or nursing women and people with any medical, psychiatric, debilitating disease/disorder or social condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol, ability to give ICF or complete the protocol.
- subjects with total and partial colectomy.
- subjects who received oral, intramuscular, or intravenous antibiotics within three months before screening.
- Patients with perianal disease usually receive recurrent antibiotics and, therefore, will be excluded from the study.
- patients with an ongoing symptomatic IBD flare or a flare within the previous three months
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- patients with estimated glomerular filtration rates (eGFR) < 60 ml/min/1.73 m2 calculated by the CKD-EPI equation measured anytime within the preceding year.
- An individual who meets any of the following criteria will be excluded from participation in this study as a healthy control:
- pregnant or nursing women and people with any medical, psychiatric, debilitating disease/disorder or social condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol, ability to give ICF or complete the protocol.
- subjects with total and partial colectomy.
- subjects who received oral, intramuscular, or intravenous antibiotics within three months before screening.
- Patients with perianal disease usually receive recurrent antibiotics and, therefore, will be excluded from the study.
- patients with an ongoing symptomatic IBD flare or a flare within the previous three months
- patients with estimated glomerular filtration rates (eGFR) < 60 ml/min/1.73 m2 calculated by the CKD-EPI equation measured anytime within the preceding year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Lama Nazzal, MD, Lama.Nazzal@nyulangone.org
Lama Nazzal, MD
About this study
Official title: Gut Kidney Axis in Enteric Hyperoxaluria: A Clinical Prospective Study of the Effects of the Microbiome on Urinary Oxalate in Participants With Enteric Hyperoxaluria Fed a Moderate Oxalate Diet
40 subjects with a confirmed diagnosis of IBD or >6 months post-RYGB with a diagnosed USD event or kidney stone on imaging within the past three years and 40 healthy controls will be administered a high oxalate diet on Days 0-3 and Days 21-24 with a washout period on Days 4-7 and will be administered 250mg sodium oxalate on Days 8-20, via prepared spinach, from Weil Cornell Medicine's Clinical and Translational Science Center. Subjects will partake in four stool collections, four 24-h urine collections, two blood collections, and four sets of colonic permeability testing.
- Conditions
- Enteric Hyperoxaluria
- Being tested
- Moderately High Oxalate (MOx) Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderately High Oxalate (MOx) DietOther
Diets will contain 16% protein, 30% fat, and 54% carbohydrate, and are controlled in the amounts of calcium (400mg), oxalate (250mg), ascorbic acid (50mg), fiber (30 grams) and, other nutrients. Each controlled diet will be consumed for four days. On days of controlled diets, subjects will be provided with 2 liters of bottled water per day to ensure adequate hydration. After the controlled diet period, there will be a three-day washout period, where participants will consume Ad-lib diets supplemented with a daily intake of oxalate in the form of cooked spinach to be taken with breakfast daily for a total of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Active comparator | Not described Receives: Other: Moderately High Oxalate (MOx) Diet |
| Enteric Hyperoxaluria | Experimental | Not described Receives: Other: Moderately High Oxalate (MOx) Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Oxalate Levels (UOx)
UOx will be quantified in 24-h samples
Measured: Day 2-3
Urinary Oxalate Levels (UOx)
UOx will be quantified in 24-h samples
Measured: Day 23-24
Secondary outcomes (11)
Total Fecal Oxalate Levels
Measured: Day 2-3
Total Fecal Oxalate Levels
Measured: Day 14
Total Fecal Oxalate Levels
Measured: Day 23-24
Urinary Calcium Levels
Measured: Day 2-3
Urinary Calcium Levels
Measured: Day 23-24
Sucralose Levels
Measured: Day 2-3
Sucralose Levels
Measured: Day 23-24
Calcium Oxalate (CaOx) Supersaturation Levels
Measured: Day 2-3
Calcium Oxalate (CaOx) Supersaturation Levels
Measured: Day 23-24
Plasma Oxalate Levels
Measured: Day 2-3
Plasma Oxalate Levels
Measured: Day 23-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start10 Nov 2022
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteric HyperoxaluriaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lama Nazzal, MD, Study chair, NYU Langone HealthDavid Goldfarb, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124886
- Sponsor's protocol ID
- 21-01274
- Other IDs
- R01DK128842
- Status last verified
- May 2026
- First submitted
- 3 Nov 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected for this study will be analyzed and stored at the Nazzal-hyperoxaluria data repository. After the study is completed, the de-identified, archived data will and stored at the Nazzal- hyperoxaluria data repository, under the supervision of Dr. Lama Nazzal, for use by other researchers including those outside of the study. Permission to transmit data to the Nazzal-hyperoxaluria data repository will be included in the informed consent. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Kidney Axis in Enteric Hyperoxaluria: A Clinical Prospective Study of the Effects of the Microbiome on Urinary Oxalate in Participants With Enteric Hyperoxaluria Fed a Moderate Oxalate Diet
- ClinicalTrials.gov ID
- NCT05124886
- Acronym / sponsor ID
- 21-01274
- Conditions
- Enteric Hyperoxaluria
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 18 Nov 2021 (actual)
- 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.
40 subjects with a confirmed diagnosis of IBD or >6 months post-RYGB with a diagnosed USD event or kidney stone on imaging within the past three years and 40 healthy controls will be administered a high oxalate diet on Days 0-3 and Days 21-24 with a washout period on Days 4-7 and will be administered 250mg sodium oxalate on Days 8-20, via prepared spinach, from Weil Cornell Medicine's Clinical and Translational Science Center. Subjects will partake in four stool collections, four 24-h urine collections, two blood collections, and four sets of colonic permeability testing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Active comparator | Other: Moderately High Oxalate (MOx) Diet |
| Enteric Hyperoxaluria | Experimental | Other: Moderately High Oxalate (MOx) Diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Subjects > 18 years and < 80 years of age
- a confirmed diagnosis of IBD or > 6 months post- RYGB, with a diagnosis USD event (renal colic with spontaneous stone passage, emergency room visits, or urological interventions) or have kidney stone on imaging (CT, MRI, or US) in the previous three years.
- We will include all racial and ethnic groups, and both men and women.
- In order to be eligible in this study as a healthy control, an individual must meet all of the following criteria:
Key exclusion criteria (14 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- pregnant or nursing women and people with any medical, psychiatric, debilitating disease/disorder or social condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol, ability to give ICF or complete the protocol.
- subjects with total and partial colectomy.
- subjects who received oral, intramuscular, or intravenous antibiotics within three months before screening.
- Patients with perianal disease usually receive recurrent antibiotics and, therefore, will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderately High Oxalate (MOx) DietDiets will contain 16% protein, 30% fat, and 54% carbohydrate, and are controlled in the amounts of calcium (400mg), oxalate (250mg), ascorbic acid (50mg), fiber (30 grams) and, other nutrients. Each controlled diet will be consumed for four days. On days of controlled diets, subjects will be provided with 2 liters of bottled water per day to ensure adequate hydration. After the controlled diet period, there will be a three-day washout period, where participants will consume Ad-lib diets supplemented with a daily intake of oxalate in the form of cooked spinach to be taken with breakfast daily for a total of 2 weeks. | Other | Enteric Hyperoxaluria, Healthy Controls |
Primary outcome
Urinary Oxalate Levels (UOx)
Time frame: Day 2-3
UOx will be quantified in 24-h samples
Urinary Oxalate Levels (UOx)
Time frame: Day 23-24
UOx will be quantified in 24-h samples
11 secondary outcomes
Total Fecal Oxalate Levels
Time frame: Day 2-3
Total Fecal Oxalate Levels
Time frame: Day 14
Total Fecal Oxalate Levels
Time frame: Day 23-24
Urinary Calcium Levels
Time frame: Day 2-3
Urinary Calcium Levels
Time frame: Day 23-24
Sucralose Levels
Time frame: Day 2-3
Sucralose Levels
Time frame: Day 23-24
Calcium Oxalate (CaOx) Supersaturation Levels
Time frame: Day 2-3
Calcium Oxalate (CaOx) Supersaturation Levels
Time frame: Day 23-24
Plasma Oxalate Levels
Time frame: Day 2-3
Plasma Oxalate Levels
Time frame: Day 23-24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. Data collected for this study will be analyzed and stored at the Nazzal-hyperoxaluria data repository. After the study is completed, the de-identified, archived data will and stored at the Nazzal- hyperoxaluria data repository, under the supervision of Dr. Lama Nazzal, for use by other researchers including those outside of the study. Permission to transmit data to the Nazzal-hyperoxaluria data repository will be included in the informed consent. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.
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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.
Lama Nazzal, MD study chair
NYU Langone Health
David Goldfarb, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderately High Oxalate (MOx) Diet in people with Enteric Hyperoxaluria, run by NYU Langone Health 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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lama Nazzal, MD (212-263-2922, Lama.Nazzal@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Oxalate Levels (UOx) (time frame: Day 2-3). The study lists 2 primary outcomes in all. 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 7 May 2026.