RECRUITING

Gut Kidney Axis in Enteric Hyperoxaluria

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2022-11-10

Study Completion:2025-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05124886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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. * 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.

Inclusion Criteria

Exclusion 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.
* 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.

* 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.
* 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.

Contacts and Locations

Study Contact

Lama Nazzal, MD

CONTACT

212-263-2922

Lama.Nazzal@nyulangone.org

David Goldfarb, MD

CONTACT

212-263-0744

David.Goldfarb@nyulangone.org

Principal Investigator

Lama Nazzal, MD

STUDY_CHAIR

NYU Langone Health

David Goldfarb, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Lama Nazzal, MD, STUDY_CHAIR, NYU Langone Health
David Goldfarb, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-10

Study Completion Date2025-11-01

Study Record Updates

Study Start Date2022-11-10

Study Completion Date2025-11-01

Terms related to this study

Additional Relevant MeSH Terms

Enteric Hyperoxaluria