Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria

Overview

Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease that can substantially impair quality of life in children and adolescents. Pharmacological treatment may not adequately control symptoms in all patients, increasing interest in dietary interventions. This randomized controlled trial aims to compare the effects of a Mediterranean diet and a low-histamine diet, in addition to standard medical treatment, on disease activity, disease control, and quality of life in pediatric patients aged 12-18 years with chronic spontaneous urticaria. Participants will be allocated to one of three groups: standard treatment alone, standard treatment plus a low-histamine diet, or standard treatment plus a Mediterranean diet. The dietary intervention will last four weeks, with follow-up through eight weeks.

Chronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized by recurrent pruritic skin lesions during childhood and has a significant negative impact on quality of life. Since its etiology is often unknown, treatment approaches generally focus on symptom control. However, pharmacological treatments do not always provide an adequate response, increasing the importance of complementary dietary approaches. In recent years, the Mediterranean diet, known for its anti-inflammatory properties, and the low-histamine diet, which restricts foods with a high histamine content, have emerged as promising options for the management of CSU symptoms. However, no controlled study has directly compared these two dietary approaches in the pediatric population. This study is planned as a three-arm randomized controlled clinical trial aiming to compare the effects of Mediterranean and low-histamine dietary interventions on disease activity, disease control, and quality of life in children aged 12-18 years diagnosed with chronic spontaneous urticaria. The intervention period will last four weeks, and assessments will be performed at baseline and at the end of the fourth week. The study will use the Urticaria Activity Score over 7 days (UAS7), the Urticaria Control Test (UCT), quality of life questionnaires (Children's Dermatology Life Quality Index \[CDLQI\] and Dermatology Life Quality Index \[DLQI\]), and the Mediterranean Diet Quality Index for Children and Adolescents (KIDMED). Dietary patterns will be assessed using a Food Frequency Questionnaire (FFQ) at baseline and monitored during the intervention period through weekly 24-hour dietary recalls and Dietary Adherence Follow-up Forms. In addition, routinely obtained clinical laboratory parameters, including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), total immunoglobulin E (total IgE), thyroid function tests (TSH and fT4), thyroid autoantibodies (anti-TPO and anti-Tg), complete blood count, and 25-hydroxyvitamin D \[25(OH)D\] levels, will be evaluated at baseline. This study is expected to fill an important gap in the current literature by demonstrating the effectiveness of dietary approaches in pediatric chronic spontaneous urticaria and to contribute to clinical practice.