Gut Kidney Axis in Enteric Hyperoxaluria

Conditions

• Enteric Hyperoxaluria

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• Moderately High Oxalate (MOx) Diet — OTHER
  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 supplemented with a daily intake of oxalate in the form of cooked spinach to be taken with breakfast daily for a total of 2 weeks.

Study Details

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.

Key Dates

Start date

Nov 10, 2022

Status verified

May 2026

Primary completion

Mar 1, 2028

Completion

Mar 1, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Active Comparator: Healthy Controls
• Experimental: Enteric Hyperoxaluria

Primary Outcome Measure

Urinary Oxalate Levels (UOx) [ Time Frame: Day 2-3 ]

Central Contacts

• Lama Nazzal, MD
  212-263-2922
  [email protected]
• David Goldfarb, MD
  212-263-0744
  [email protected]

Locations (1)

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