NYU Langone Health
New York, 10016, United States
Location status: Recruiting
Location contact
David Goldfarb, MD
PRINCIPAL_INVESTIGATOR
Lama Nazzal, MD
CONTACT
Lama Nazzal, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05124886
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
New York, 10016, United States
Location status: Recruiting
David Goldfarb, MD
PRINCIPAL_INVESTIGATOR
Lama Nazzal, MD
CONTACT
Lama Nazzal, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
In order to be eligible in this study as a healthy control, an individual must meet all of the following criteria:
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
An individual who meets any of the following criteria will be excluded from participation in this study as a healthy control:
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.
Time frame: Day 2-3
UOx will be quantified in 24-h samples
Time frame: Day 23-24
UOx will be quantified in 24-h samples
Time frame: Day 2-3
Time frame: Day 14
Time frame: Day 23-24
Time frame: Day 2-3
Time frame: Day 23-24
Time frame: Day 2-3
Time frame: Day 23-24
Time frame: Day 2-3
Time frame: Day 23-24
Time frame: Day 2-3
Time frame: Day 23-24
Contact information is provided by the study sponsor or research team.
David Goldfarb, MD
CONTACT
Lama Nazzal, MD
CONTACT
NYU Langone Health
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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