Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria

Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative stress with CSU presence, disease activity, and response to omalizumab. Adults with active CSU and age/BMI-matched healthy controls will provide non-consecutive 3-day dietary records (two weekdays and one weekend day). Dietary antioxidant capacity will be calculated using ORAC metrics via BeBiS software. Oxidative stress biomarkers (total oxidant status, total antioxidant status, oxidative stress index, malondialdehyde, and advanced oxidation protein products) will be measured from venous blood samples. CSU disease activity will be assessed using UAS7 and UCT, along with an urticaria quality of life questionnaire. In CSU patients who receive omalizumab as clinically indicated, assessments will be repeated after 3 months to evaluate treatment response and associated changes in diet and oxidative stress markers.

NCT Number	NCT07431658
Lead Sponsor	Istanbul Training and Research Hospital
Conditions	Chronic Spontaneous Urticaria (CSU)
Enrollment	116 participants
Start Date	2025-12-01
Primary Completion	2026-12 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-02-27