Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria (NCT07765979) | Clinical Trial Compass
RecruitingNot Applicable
Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria
Turkey (Türkiye)63 participantsStarted 2025-11-23
Plain-language 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.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.