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NCT Number: NCT05124886

Gut Kidney Axis in Enteric Hyperoxaluria

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

David Goldfarb, MD

PRINCIPAL_INVESTIGATOR

Lama Nazzal, MD

CONTACT

[email protected]

Lama Nazzal, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Urinary Oxalate Levels (UOx)

    Time frame: Day 2-3

    UOx will be quantified in 24-h samples

  2. Urinary Oxalate Levels (UOx)

    Time frame: Day 23-24

    UOx will be quantified in 24-h samples

Secondary outcomes

  1. Total Fecal Oxalate Levels

    Time frame: Day 2-3

  2. Total Fecal Oxalate Levels

    Time frame: Day 14

  3. Total Fecal Oxalate Levels

    Time frame: Day 23-24

  4. Urinary Calcium Levels

    Time frame: Day 2-3

  5. Urinary Calcium Levels

    Time frame: Day 23-24

  6. Sucralose Levels

    Time frame: Day 2-3

  7. Sucralose Levels

    Time frame: Day 23-24

  8. Calcium Oxalate (CaOx) Supersaturation Levels

    Time frame: Day 2-3

  9. Calcium Oxalate (CaOx) Supersaturation Levels

    Time frame: Day 23-24

  10. Plasma Oxalate Levels

    Time frame: Day 2-3

  11. Plasma Oxalate Levels

    Time frame: Day 23-24

Study contacts

Contact information is provided by the study sponsor or research team.

David Goldfarb, MD

CONTACT

[email protected]

212-263-0744

Lama Nazzal, MD

CONTACT

[email protected]

212-263-2922

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Nov 18, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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