Mediterranean and Low-Histamine Diets for pediatric chronic spontaneous urticaria
Official title: The Effects of the Mediterranean and Low-Histamine Diets on Disease Severity in Pediatric Chronic Spontaneous Urticaria
Run by Saglik Bilimleri Universitesi · NCT07765979 · Data updated 2026-11-12
This study tests whether adding a Mediterranean diet or a low-histamine diet to standard care helps 12- to 18-year-olds with chronic spontaneous urticaria feel better and have fewer symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 18 Years |
| Sex | All |
| Enrollment | 63 (estimated) |
| Sponsor | Saglik Bilimleri Universitesi Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Status | Recruiting |
| Started | November 23, 2025 |
| Main results expected | January 15, 2027 |
| Study ends | January 15, 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07765979 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ages 12-18 with chronic spontaneous urticaria, not recently on systemic corticosteroids or immunosuppressive therapy (except short-term use), and who can provide informed consent.
✕Probably not a fit
Patients with other chronic diseases, neurodevelopmental disorders, or those requiring a special therapeutic diet may not benefit, and those with recent or persistent use of certain medications or acute infections are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, three-arm trial compares standard treatment alone to standard treatment plus a Mediterranean diet or plus a low-histamine diet in adolescents with chronic spontaneous urticaria. The dietary interventions run for four weeks, with assessments at baseline and week four. Outcomes include disease activity (UAS7), disease control (UCT), and quality of life (CDLQI and DLQI), along with a diet quality index for children and adolescents. The study aims to determine which dietary approach, if either, provides greater benefit alongside standard therapy. Participants are 12–18 years old and must meet specific clinical criteria and provide informed consent.
Why it matters
Potential benefit: If successful, the dietary approaches could offer an additional way to reduce symptoms and improve quality of life for young people with CSU.
How similar studies have gone: There is limited direct evidence from pediatric trials comparing Mediterranean and low-histamine diets for CSU; this study addresses that gap with a randomized design.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
Istanbul, Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Deniz ÖZÇEKER, Prof. Dr.
- Email: denizozceker@gmail.com
- Phone: +90 532 349 8116
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.