Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT05124886

Conditions

Enteric Hyperoxaluria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Moderately High Oxalate (MOx) Diet

Study Details

Brief 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

Study ID

NCT05124886

Start date

Nov 10, 2022

Status verified date

May, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Healthy Controls

experimental: Enteric Hyperoxaluria

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Lama Nazzal, MD

More Information

Sponsor

NYU Langone Health

Last update posted

May 7, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-07.