Gut Kidney Axis in Enteric Hyperoxaluria

NCT ID: NCT05124886

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-10
• Study Completion Date: 2026-03-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy Controls

Group Type: ACTIVE_COMPARATOR

Moderately High Oxalate (MOx) Diet

Intervention Type: 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

Group Type: EXPERIMENTAL

Moderately High Oxalate (MOx) Diet

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lama Nazzal, MD

Role: STUDY_CHAIR

NYU Langone Health

David Goldfarb, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lama Nazzal, MD

Role: CONTACT

Lama.Nazzal@nyulangone.org

212-263-2922

David Goldfarb, MD

Role: CONTACT

David.Goldfarb@nyulangone.org

212-263-0744

Facility Contacts

Lama Nazzal, MD

Role: primary

Lama.Nazzal@nyulangone.org

Other Identifiers

R01DK128842

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-01274

Identifier Type: -

Identifier Source: org_study_id