Clinical trial NCT05124886: Gut Kidney Axis in Enteric Hyperoxaluria
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Enteric Hyperoxaluria
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Urinary Oxalate Levels (UOx)
timeFrame: Day 2-3
measure: Urinary Oxalate Levels (UOx)
timeFrame: Day 23-24
Secondary outcomes:
measure: Total Fecal Oxalate Levels
timeFrame: Day 2-3
measure: Total Fecal Oxalate Levels
timeFrame: Day 14
measure: Total Fecal Oxalate Levels
timeFrame: Day 23-24
measure: Urinary Calcium Levels
timeFrame: Day 2-3
measure: Urinary Calcium Levels
timeFrame: Day 23-24
measure: Sucralose Levels
timeFrame: Day 2-3
measure: Sucralose Levels
timeFrame: Day 23-24
measure: Calcium Oxalate (CaOx) Supersaturation Levels
timeFrame: Day 2-3
measure: Calcium Oxalate (CaOx) Supersaturation Levels
timeFrame: Day 23-24
measure: Plasma Oxalate Levels
timeFrame: Day 2-3
measure: Plasma Oxalate Levels
timeFrame: Day 23-24
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lama Nazzal, MD
role: STUDY_CHAIR
affiliation: NYU Langone Health
name: David Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References: