The Effects of the Mediterranean and Low-Histamine Diets on Disease Severity in Pediatric Chronic Spontaneous Urticaria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Urticaria Activity Score (UAS7)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-18 years.
- •Confirmed diagnosis of Chronic Spontaneous Urticaria (CSU) according to international guidelines.
- •No recent use of systemic corticosteroids or immunosuppressive therapy (except short-term acute use).
- •Written informed consent provided by both the participant and a parent/legal guardian.
排除标准
- •Presence of a neurodevelopmental disorder.
- •Presence of any other known chronic disease.
- •Presence of a disease requiring a special therapeutic diet.
- •Presence of an acute infection.
- •Presence of any food allergy.
- •Recent use of systemic corticosteroids, biologic agents, - immunosuppressive therapy, or high-dose antihistamines (except short-term acute use).
研究组 & 干预措施
Low-Histamine Diet
Participants receive a low-histamine diet in addition to standard medical treatment.
干预措施: Low-Histamine Diet (Other)
Mediterranean diet
Participants receive a Mediterranean diet in addition to standard medical treatment.
干预措施: Mediterranean Diet (Other)
Control
Participants receive standard medical treatment only without any dietary intervention.
结局指标
主要结局
Urticaria Activity Score (UAS7)
时间窗: 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).
次要结局
- Urticaria Control Test (UCT)(Baseline (Day 0), Week 4, and Week 8)
- Dermatology Life Quality Index (CDLQI/DLQI)(Baseline (Day 0), Week 4, and Week 8)
- Diet adherence(Weeks 2, 3, 4 and Week 8)
- KIDMED Index(Baseline (Day 0), Week 4, and Week 8)