Spinach test reveals Gut's role in kidney stones
NCT ID NCT05124886
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
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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
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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Other studies related to the condition(s) this trial covers.
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- Could IBD medications during pregnancy shape a Child's development?
- Can AI learn to grade endoscopy quality from video?
- Can a simple tool predict who will be Stone-Free after kidney surgery?