Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT05124886

Gut Kidney Axis in Enteric Hyperoxaluria

Led by NYU Langone Health · Updated on 2026-05-07

80

Participants Needed

1

Research Sites

276 weeks

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Gut Kidney Axis in Enteric Hyperoxaluria

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects between 18 and 80 years of age
  • Confirmed diagnosis of inflammatory bowel disease or more than 6 months after Roux-en-Y gastric bypass surgery, with a kidney stone event or stone seen on imaging in the last three years
  • Includes all races and ethnicities, both men and women
  • Healthy controls must be between 18 and 80 years old
  • Healthy controls must have no chronic diseases, no chronic medications, no history of gastrointestinal problems or kidney stones
  • Includes all races and ethnicities, both men and women
Not Eligible

You will not qualify if you...

  • Pregnant or nursing women
  • People with medical, psychiatric, or debilitating conditions or social situations that prevent following the study or giving consent
  • People who had total or partial colectomy
  • People who took antibiotics by mouth, injection, or intravenously within the last three months
  • Patients with perianal disease who often take antibiotics
  • Patients with an active or recent (within 3 months) flare of inflammatory bowel disease
  • Patients with kidney function below an estimated glomerular filtration rate of 60 ml/min/1.73 m2 measured in the past year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

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Research Team

L

Lama Nazzal, MD

CONTACT

D

David Goldfarb, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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