Gut Kidney Axis in Enteric Hyperoxaluria
- Conditions
- Enteric Hyperoxaluria
- Interventions
- Other: Moderately High Oxalate (MOx) Diet
- Registration Number
- NCT05124886
- Lead Sponsor
- NYU Langone Health
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Controls Moderately High Oxalate (MOx) Diet - Enteric Hyperoxaluria Moderately High Oxalate (MOx) Diet -
- Primary Outcome Measures
Name Time Method Urinary Oxalate Levels (UOx) Day 23-24 UOx will be quantified in 24-h samples
- Secondary Outcome Measures
Name Time Method Sucralose Levels Day 23-24 Calcium Oxalate (CaOx) Supersaturation Levels Day 23-24 Plasma Oxalate Levels Day 23-24 Total Fecal Oxalate Levels Day 23-24 Urinary Calcium Levels Day 23-24
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States