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 Type
OBSERVATIONAL
Enrollment
13
Patients will be placed on gluten free diet for 9-12 months.
New York University School of Medicine
New York, New York, United States
Change in disease activity measured by relapse rate
Response is defined as a ≥50%decrease in relapse rate
Time frame: 12 Months
Change in disease activity measured by change in dosage of corticosteroids and immunosuppressive medications
reduction by ≥1 drug in exposure to immunosuppressive medications in response to the GFD
Time frame: 12 Months
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