Gut Kidney Axis in Enteric Hyperoxaluria

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Gut Kidney Axis in Enteric Hyperoxaluria

Condition
Enteric Hyperoxaluria
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

NYU Langone Health,

Lama Nazzal, MD, STUDY_CHAIR, NYU Langone Health

David Goldfarb, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2025-11-01