RecruitingNot ApplicableNCT05124886

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

Sponsor

NYU Langone Health

Enrollment

80 participants

Start Date

Nov 10, 2022

Study Type

INTERVENTIONAL

Conditions

Enteric Hyperoxaluria

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study examines how the gut and kidney interact in people who form kidney stones due to high oxalate in their urine — a condition called enteric hyperoxaluria. This often occurs in people with inflammatory bowel disease (IBD) or after Roux-en-Y gastric bypass (RYGB) weight-loss surgery. Researchers will analyze gut bacteria, urine, and blood samples to understand the gut-kidney connection and find ways to prevent stone formation. You may be eligible if... - You are between 18 and 80 years old - You have a diagnosis of IBD OR have had RYGB surgery more than 6 months ago, AND you have a history of kidney stones or a kidney stone seen on imaging in the past 3 years - OR you are a healthy volunteer with no chronic diseases or history of kidney stones or gut problems You may NOT be eligible if... - You are pregnant or nursing - You have had a total or partial colectomy (colon removal) - You have taken oral or IV antibiotics in the past 3 months - You have an ongoing or recent (past 3 months) IBD flare - Your kidney function is reduced (eGFR below 60) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERModerately 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.

Locations(1)

NYU Langone Health

New York, New York, United States

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NCT05124886