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Gut Kidney Axis in Enteric Hyperoxaluria

NYU Langone Health · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05124886

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
80
US sites recruiting
1
Study start
November 10, 2022
Record last updated
May 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Moderately High Oxalate (MOx) Diet

Conditions: Enteric Hyperoxaluria

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • NYU Langone Health

    New York, NY 10016

    Site contact: Lama Nazzal, MD · Lama.Nazzal@nyulangone.org

Study contacts (from the official record)

  • Lama Nazzal, MD · 212-263-2922 · Lama.Nazzal@nyulangone.org
  • David Goldfarb, MD · 212-263-0744 · David.Goldfarb@nyulangone.org
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Gut Kidney Axis in Enteric Hyperoxaluria (NCT05124886) | Bored Studies