Spinach test reveals Gut's role in kidney stones

NCT ID NCT05124886

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the gut and kidneys work together in people with enteric hyperoxaluria, a condition that raises the risk of kidney stones. Researchers will give participants a high-oxalate diet (like spinach) and measure oxalate levels in urine and stool. The goal is to understand how gut bacteria affect oxalate absorption and stone formation, which could lead to better prevention strategies.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: 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 * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

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