Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria

Condition(s) studied

Investigational drug(s) / intervention(s)

Low-Histamine Diet: Participants assigned to this intervention will receive a low-histamine diet in addition to standard medical treatment for 4 weeks.

Mediterranean Diet: Participants assigned to this intervention will receive a Mediterranean diet in addition to standard medical treatment for 4 weeks.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Urticaria Activity Score (UAS7) — Baseline (Day 0), Week 4, and Week 8
  Disease activity will be assessed using the Urticaria Activity Score over 7 days (UAS7). Changes in UAS7 scores will be evaluated at baseline, Week 4 (end of intervention), and Week 8 (follow-up).

Trial sites (1)

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