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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1
NYU Langone Health
New York, New York, United States, 10016