Investigating the relationship between gut health and kidney stones in certain patients

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

This study is testing how a high oxalate diet affects kidney stone formation in people with inflammatory bowel disease or those who have had gastric bypass surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05124886 on ClinicalTrials.gov

What this trial studies

This study involves 40 subjects with inflammatory bowel disease (IBD) or those who have undergone Roux-en-Y gastric bypass (RYGB) and have experienced kidney stones, along with 40 healthy controls. Participants will follow a high oxalate diet for specific periods and will undergo various tests, including stool and urine collections, blood tests, and colonic permeability assessments. The goal is to understand how dietary oxalate affects kidney stone formation in these populations.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with IBD or those who are more than six months post-RYGB and have a history of kidney stones.

Not a fit: Patients without a history of gastrointestinal issues or kidney stones, or those with chronic diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better dietary recommendations and management strategies for patients at risk of kidney stones.

How similar studies have performed: While the specific approach of this study may be novel, similar studies have explored dietary impacts on kidney stone formation with varying degrees of success.

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.

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: David Goldfarb, MD — NYU Langone Health
• Study coordinator: Lama Nazzal, MD

Conditions Enteric Hyperoxaluria