NCT05124886RecruitingNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Urinary Oxalate Levels (UOx)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Urinary Oxalate Levels (UOx)
Time Frame: Day 23-24
UOx will be quantified in 24-h samples
Secondary Outcomes
- 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)
- Sucralose Levels(Day 23-24)
Investigators
Study Sites (1)
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