NCT05124886

Gut Kidney Axis in Enteric Hyperoxaluria

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Enteric Hyperoxaluria

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2022-11-10
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2021-11-18
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States