Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients A Pragmatic Trial (EVOLUTION).
This research study is being conducted to determine whether switching to an IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) for patients with PsA who had an inadequate response to a TNFi. Guselkumab and Golimumab are prescription medicines that have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of active psoriatic arthritis in adults. You may be eligible to receive the medication without participation in this study. This study will also investigate whether determine whether more frequent dosing of GUS (every 4 weeks), a higher dose than the currently approved dose, is more effective than GUS every 8 weeks (the currently approved dosing).
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
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 subjects 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.Subjects are placed on prepared-controlled diets obtained from the metabolic kitchen at Weill Cornell Medicine’s Clinical and Translation Science Center with moderately high oxalate (MOx) during Days 0-3 and Days 21-24. 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. The MOx diet will be compared against healthy controls with no chronic diseases, not on any chronic medications, no history of GI pathology, or urinary stone disease (USD).
Gut microbiome alterations as a mechanism of immune dysregulation in new-onset refractory status epilepticus (NORSE)
We will perform a prospective, observational cohort study, with biospecimen collection, of NORSE subjects and subjects with status epilepticus of known cause (e.g. epilepsy, stroke, traumatic brain injury) serving as disease controls. Biospecimens to be collected include serum, CSF, and feces, which will all be analyzed in conjunction with relevant clinical outcome measures collected via prospective chart reviews of these subjects' hospital stays. These analyses will allow us to test our hypothesis that in subjects with status epilepticus, gut dysbiosis leads to IL-1b upregulation, which enhances neuronal hyperexcitability and contributes to refractory status epilepticus.
Gut Microbiome in Food Protein-Induced Enterocolitis Syndrome: An Observational Study
Food protein-induced enterocolitis syndrome (FPIES) is a non IgE-mediated food allergy that manifests with predominantly gastrointestinal symptoms and usually starts in the first year of life. There is no diagnostic biomarker and no treatment for FPIES beyond food avoidance, reflecting poorly understood pathophysiology. This is a prospective observational study, which will compare fecal microbiota, fecal short chain fatty acids and metabolomics between infants with FPIES and control infants and infants without food allergy, 0-12 months old. It will also compare mucosal immunity via epigenetic markers in blood in infants with FPIES, and infants with IgE-mediated food allergy. Stool samples will be collected from 50 infants with FPIES and 50 sex and age matched control infants birth through 12 months. Optional blood samples will be collected only from infants with FPIES and infants with IgE-mediated food allergies (0-12 months old). A questionnaire will be used to obtain information detailing the infant’s feeding, medical, birth, and family history.
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