BridgeMD
New treatment option for Enteric Hyperoxaluria
Official title Gut Kidney Axis in Enteric Hyperoxaluria
ClinicalTrials.gov ID: NCT05124886
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- people \> 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...
- 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...
- people \> 18 years and \< 80 years of age
You likely can't join if
- 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...
- people with total and partial colectomy.
- people 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
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- people \> 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...
- 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:
- people \> 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.
- 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...
- people with total and partial colectomy.
- people 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...
- 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...
- people with total and partial colectomy.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.