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RecruitingNCT05124886Updated May 7, 2026

Gut Kidney Axis in Enteric Hyperoxaluria

An interventional study of Moderately High Oxalate (MOx) Diet in Enteric Hyperoxaluria, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Nov 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Enteric Hyperoxaluria
03

In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Healthy Controls

    Other: Moderately High Oxalate (MOx) Diet

  • Experimental
    Enteric Hyperoxaluria

    Other: Moderately High Oxalate (MOx) Diet

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.

06

What researchers measure

Primary outcomes

  1. Urinary Oxalate Levels (UOx)

    UOx will be quantified in 24-h samples

    Time frame: Day 2-3

  2. Urinary Oxalate Levels (UOx)

    UOx will be quantified in 24-h samples

    Time frame: Day 23-24

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

07

Study locations

1 of 1 sites recruiting
  • NYU Langone Health
    New York, New York 10016, United States
    • Lama Nazzal, MD · Contact · Lama.Nazzal@nyulangone.org
    • Lama Nazzal, MD · Principal investigator
    • David Goldfarb, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Data collected for this study will be analyzed and stored at the Nazzal-hyperoxaluria data repository. After the study is completed, the de-identified, archived data will and stored at the Nazzal- hyperoxaluria data repository, under the supervision of Dr. Lama Nazzal, for use by other researchers including those outside of the study. Permission to transmit data to the Nazzal-hyperoxaluria data repository will be included in the informed consent. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05124886
Lead sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Nov 18, 2021
Start date
Nov 10, 2022
Primary completion
Mar 1, 2028 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
May 7, 2026

Study contacts

Lama Nazzal, MD
Contact
Lama.Nazzal@nyulangone.org
212-263-2922
David Goldfarb, MD
Contact
David.Goldfarb@nyulangone.org
212-263-0744
Lama Nazzal, MD
study chair · NYU Langone Health
David Goldfarb, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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