Gut Kidney Axis in Enteric Hyperoxaluria

NCT05124886 | Recruiting

• 2 other identifiers: 21-01274R01DK128842
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Urinary Oxalate Levels (UOx)

  UOx will be quantified in 24-h samples

  Day 2-3

• Urinary Oxalate Levels (UOx)

  UOx will be quantified in 24-h samples

  Day 23-24

Secondary Outcomes (11)

• Total Fecal Oxalate Levels

  Day 2-3

• Total Fecal Oxalate Levels

  Day 14

• Total Fecal Oxalate Levels

  Day 23-24

• Urinary Calcium Levels

  Day 2-3

• Urinary Calcium Levels

  Day 23-24

Study Arms (2)

Healthy Controls

ACTIVE COMPARATOR

Other: Moderately High Oxalate (MOx) Diet

Enteric Hyperoxaluria

EXPERIMENTAL

Other: Moderately High Oxalate (MOx) Diet

Interventions

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.

Enteric Hyperoxaluria; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lama Nazzal, MD

  NYU Langone Health

  STUDY CHAIR

• David Goldfarb, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lama Nazzal, MD

CONTACT

212-263-2922; Lama.Nazzal@nyulangone.org

David Goldfarb, MD

CONTACT

212-263-0744; David.Goldfarb@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 18, 2021
• Study Start: November 10, 2022
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to lama.nazzal@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)