Actively Recruiting
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
Led by NYU Langone Health · Updated on 2026-05-07
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the gut-kidney connection in people with enteric hyperoxaluria, a condition linked to kidney stones and related to inflammatory bowel disease (IBD) or Roux-en-Y gastric bypass (RYGB) surgery. The study will compare 40 participants with these conditions to 40 healthy controls to understand how the gut microbiome affects urinary oxalate levels. This prospective clinical study is sponsored by NYU Langone Health and focuses on how diet influences oxalate metabolism in these groups. Participants will follow a controlled diet with moderately high oxalate content for specific periods (Days 0-3 and 21-24) and consume sodium oxalate via prepared spinach from Days 8-20. There is a washout period on Days 4-7 where participants eat ad-lib diets supplemented with daily spinach. The diets are carefully controlled for protein, fat, carbohydrate, calcium, oxalate, ascorbic acid, and fiber. During the study, hydration is maintained by providing bottled water daily. Participants will provide multiple biological samples including four stool collections, four 24-hour urine collections, and two blood samples. Colonic permeability will also be tested four times. The main measurements are urinary oxalate levels on Days 2-3 and 23-24. Additional measurements include fecal oxalate, urinary calcium, sucralose, calcium oxalate supersaturation, and plasma oxalate levels at various time points. The study will help clarify the impact of diet and microbiome on oxalate metabolism over the study period.
CONDITIONS
Brief Title
Gut Kidney Axis in Enteric Hyperoxaluria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects are between 18 and 80 years of age
- Confirmed diagnosis of inflammatory bowel disease or more than 6 months post-Roux-en-Y gastric bypass surgery
- Diagnosis of urinary stone disease event or kidney stone on imaging within the past three years
- Healthy controls must be between 18 and 80 years of age
- Healthy controls have no chronic diseases, no chronic medications, and no history of gastrointestinal or urinary stone disease
- Includes all racial and ethnic groups and both men and women
You will not qualify if you...
- Pregnant or nursing women
- Individuals with medical, psychiatric, debilitating disease or social condition interfering with study participation or consent
- Subjects with total or partial colectomy
- Subjects who received oral, intramuscular, or intravenous antibiotics within three months before screening
- Patients with perianal disease who receive recurrent antibiotics
- Patients with ongoing or recent (within three months) inflammatory bowel disease flare
- Patients with estimated glomerular filtration rate less than 60 ml/min/1.73 m2 within the past year
- Healthy controls meeting any of the above exclusion criteria
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants follow a controlled diet containing specific amounts of protein, fat, carbohydrate, calcium, oxalate, ascorbic acid, and fiber for four days, followed by a three-day washout period and then two weeks of an ad-lib diet supplemented with daily oxalate intake from cooked spinach.
Visits around Day 2-3, Day 14, and Day 23-24 for assessments
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
L
Lama Nazzal, MD
D
David Goldfarb, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Frequently Asked Questions
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