Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker
Elevated plasma zonulin levels, which are supportive of a diagnosis of CD (celiac disease) in children with gastrointestinal symptoms, may indicate patients with difficult-to-manage NS who will benefit from initiation of a GFD (gluten free diet). This pilot study will determine whether high plasma zonulin levels can be used as a screening tool to identify patients with NS (nephrotic syndrome) who are likely to demonstrate a beneficial response to a GFD. It will provide important information about the feasibility of testing the efficacy of a GFD for this condition and assist in the design and sample size calculation for a definitive trial to test the beneficial effect of this dietary intervention. Although NS is a rare condition in childhood, it is a chronic disease that can lead to short- and long-term disability especially in those with difficult-to-manage disease. There is an urgent need to develop safe and effective new therapies in this subgroup. This project may indicate the utility of a common dietary modification, a GFD, to treat these patients. The growing medical use of and greater access to gluten-free food items underscore the feasibility and timeliness of this approach.
Study Start Date
December, 01 2017
Estimated Completion Date
- Other: Implementation of a gluten-free diet
New York University School of Medicine -- 17-01307
New York University School of Medicine
- Steroid sensitive NS: complete remission of proteinuria in response to administration of a standard course of corticosteroids
- Difficult-to-manage NS: disease that cannot be controlled without incurring intolerable side effects from currently available immunosuppressive agents, namely corticosteroids, calcineurin inhibitors, mycophenolate mofetil, or rituximab. Patients with biopsy-proven MCD or FSGS will be eligible as long as they have steroid sensitive disease. However, a renal biopsy will not be required for enrollment into the trial.
- Any patient diagnosed with nephrotic syndrome that is not considered steroid sensitive or frequently relapsing
- Pre-existing celiac disease or gastro-intestinal disorder that precludes use of a GFD
9 Months to 18 Years
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|New York University School of Medicine - New York, New York||186.5 miles||Suzanne Vento MD||646-501-2665||Suzanne.Vento@nyumc.org|