Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker

Description

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

December 2019

Interventions

  • Other: Implementation of a gluten-free diet

Study ID

New York University School of Medicine -- 17-01307

Status

Unknown

Trial ID

NCT03387176

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

40

Sponsor

New York University School of Medicine

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Gender

All

Ages

9 Months to 18 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
New York University School of Medicine - New York, New York 50.2 miles Suzanne Vento MD 646-501-2665 Suzanne.Vento@nyumc.org

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