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Gut Kidney Axis in Enteric Hyperoxaluria Study

This study is looking at how the gut and kidneys are connected in people with enteric hyperoxaluria, a condition where too much oxalate is absorbed from the gut, leading to kidney stones. Researchers want to understand how different diets affect oxalate levels in your urine. You might be able to join if you are between 18 and 80 years old and have a confirmed diagnosis of Inflammatory Bowel Disease (IBD) or had Roux-en-Y gastric bypass (RYGB) surgery more than 6 months ago, and have had kidney stone events or kidney stones seen on imaging in the last three years. The study will measure urinary oxalate levels to see the impact of the diets. The current status of the study is unclear.

Study design
This interventional study plans to enroll 80 participants, including 40 individuals with certain kidney stone conditions and 40 healthy volunteers.
What's involved
You would follow specific diets, including a Moderately High Oxalate (MOx) Diet and a diet with 250mg sodium oxalate via prepared spinach, over several weeks. You would also provide four stool samples, four 24-hour urine samples, two blood samples, and undergo four colonic permeability tests.
Compensation
Not stated in the trial record.
Follow-up
Your urinary oxalate levels will be measured at Day 2-3 and Day 23-24.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05124886

Gut Kidney Axis in Enteric Hyperoxaluria

Recruiting
NAAges 18–80Interventional
NYU Langone Health
~80 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:Moderately High Oxalate (MOx) Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Urinary Oxalate Levels (UOx)
Measured over Day 2-3
+1 more outcome measured

Conditions

Enteric Hyperoxaluria

Explore related trials

Enteric HyperoxaluriaInflammatory Bowel DiseaseUrinary System Disorder

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Lama Nazzal, MD · STUDY_CHAIR · NYU Langone Health
  • David Goldfarb, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Lama Nazzal, MD
[email protected]
212-263-2922
Email the study team

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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.

What this trial measures

  • Urinary Oxalate Levels (UOx)Day 2-3

    UOx will be quantified in 24-h samples

  • Urinary Oxalate Levels (UOx)Day 23-24

    UOx will be quantified in 24-h samples