An interventional study of Low-Histamine Diet and Mediterranean Diet in Urticaria Chronic, sponsored by Saglik Bilimleri Universitesi. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment
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.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's planned enrollment of 63 is below the median of 80 across 145 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard medical treatment only without any dietary intervention.
Participants receive a low-histamine diet in addition to standard medical treatment.
Other: Low-Histamine Diet
Participants receive a Mediterranean diet in addition to standard medical treatment.
Other: Mediterranean Diet
Participants assigned to this intervention will receive a low-histamine diet in addition to standard medical treatment for 4 weeks.
Participants assigned to this intervention will receive a Mediterranean diet in addition to standard medical treatment for 4 weeks.
Urticaria Activity Score (UAS7)
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).
Time frame: Baseline (Day 0), Week 4, and Week 8
Urticaria Control Test (UCT)
Disease control will be assessed using the Urticaria Control Test (UCT). Changes in UCT scores will be evaluated at baseline, Week 4, and Week 8.
Time frame: Baseline (Day 0), Week 4, and Week 8
Dermatology Life Quality Index (CDLQI/DLQI)
Health-related quality of life will be assessed using the Children's Dermatology Life Quality Index (CDLQI) or the Dermatology Life Quality Index (DLQI), as appropriate for participant age. Changes in scores will be evaluated at baseline, Week 4, and Week 8.
Time frame: Baseline (Day 0), Week 4, and Week 8
Diet adherence
Dietary adherence will be assessed throughout the study. Participants assigned to the low-histamine diet will be monitored using the Low-Histamine Diet Adherence Follow-up Form, whereas participants assigned to the Mediterranean diet will be monitored using a weekly dietary adherence form based on KIDMED questionnaire items.
Time frame: Weeks 2, 3, 4 and Week 8
KIDMED Index
Adherence to the Mediterranean dietary pattern will be assessed using the KIDMED Index at baseline, Week 4, and Week 8. Changes in KIDMED scores will be evaluated throughout the study.
Time frame: Baseline (Day 0), Week 4, and Week 8
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jan 2027, 13 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Saglik Bilimleri Universitesi →