Gut Kidney Axis in Enteric Hyperoxaluria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moderately High Oxalate (MOx) Diet.
- Who it may be relevant to
- Registry conditions: Enteric Hyperoxaluria. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
Interventions
- Other Moderately High Oxalate (MOx) Diet
Diets will contain 16% protein, 30% fat, and 54% carbohydrate, and are controlled in the amounts of calcium (400mg), oxalate (250mg), ascorbic acid (50mg), fiber (30 grams) and, other nutrients. Each controlled diet will be consumed for four days. On days of controlled diets, subjects will be provided with 2 liters of bottled water per day to ensure adequate hydration. After the controlled diet period, there will be a three-day washout period, where participants will consume Ad-lib diets supplem
Primary outcome measures
- Urinary Oxalate Levels (UOx) [Time frame: Day 2-3]
- Urinary Oxalate Levels (UOx) [Time frame: Day 23-24]
Secondary outcome measures (11)
- Total Fecal Oxalate Levels [Time frame: Day 2-3]
- Total Fecal Oxalate Levels [Time frame: Day 14]
- Total Fecal Oxalate Levels [Time frame: Day 23-24]
- Urinary Calcium Levels [Time frame: Day 2-3]
- Urinary Calcium Levels [Time frame: Day 23-24]
- Sucralose Levels [Time frame: Day 2-3]
- Sucralose Levels [Time frame: Day 23-24]
- Calcium Oxalate (CaOx) Supersaturation Levels [Time frame: Day 2-3]
- Calcium Oxalate (CaOx) Supersaturation Levels [Time frame: Day 23-24]
- Plasma Oxalate Levels [Time frame: Day 2-3]
- Plasma Oxalate Levels [Time frame: Day 23-24]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT05124886 · 21-01274 · R01DK128842