Status:

RECRUITING

Gut Kidney Axis in Enteric Hyperoxaluria

Lead Sponsor:

NYU Langone Health

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Enteric Hyperoxaluria

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

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 h...

Eligibility 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.

Key Trial Info

Start Date :

November 10 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2026

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT05124886

Start Date

November 10 2022

End Date

March 1 2026

Last Update

June 5 2025

Active Locations (1)

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NYU Langone Health

New York, New York, United States, 10016