NCT03387176

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 9 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nephrotic Syndrome

Interventions

Type	Name	Description
OTHER	Implementation of a gluten-free diet	Patients will be placed on gluten free diet for 9-12 months.

Timeline

• Start date: 2017-12-01
• Primary completion: 2021-06-14
• Completion: 2021-06-14
• First posted: 2017-12-29
• Last updated: 2021-06-22

Locations

1 site across 1 country: United States