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

Nephrotic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387176
• Other study ID #: 17-01307
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: June 14, 2021

Study information

• Verified date: June 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Intervention

Other:
• Implementation of a gluten-free diet
Patients will be placed on gluten free diet for 9-12 months.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease activity measured by relapse rate	Response is defined as a =50%decrease in relapse rate	12 Months
Primary	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	12 Months