Gut Kidney Axis in Enteric Hyperoxaluria

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Urinary Oxalate Levels (UOx) [Срок оценки: Day 2-3]
• Urinary Oxalate Levels (UOx) [Срок оценки: Day 23-24]

Вторичные конечные точки (11)

• Total Fecal Oxalate Levels [Срок оценки: Day 2-3]
• Total Fecal Oxalate Levels [Срок оценки: Day 14]
• Total Fecal Oxalate Levels [Срок оценки: Day 23-24]
• Urinary Calcium Levels [Срок оценки: Day 2-3]
• Urinary Calcium Levels [Срок оценки: Day 23-24]
• Sucralose Levels [Срок оценки: Day 2-3]
• Sucralose Levels [Срок оценки: Day 23-24]
• Calcium Oxalate (CaOx) Supersaturation Levels [Срок оценки: Day 2-3]
• Calcium Oxalate (CaOx) Supersaturation Levels [Срок оценки: Day 23-24]
• Plasma Oxalate Levels [Срок оценки: Day 2-3]
• Plasma Oxalate Levels [Срок оценки: Day 23-24]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT05124886 · 21-01274 · R01DK128842

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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