Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria

NCT07765979 | Recruiting

• 1 other identifier: SBU-DYT-MGT-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urticaria Chronic

Keywords

Chronic Urticaria; Mediterranean Diet; diet; histamine; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (Day 0), Week 4, and Week 8

Secondary Outcomes (4)

• 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

Study Arms (3)

Control

NO INTERVENTION

Participants receive standard medical treatment only without any dietary intervention.

Low-Histamine Diet

EXPERIMENTAL

Participants receive a low-histamine diet in addition to standard medical treatment.

Other: Low-Histamine Diet

Mediterranean diet

EXPERIMENTAL

Participants receive a Mediterranean diet in addition to standard medical treatment.

Other: Mediterranean Diet

Interventions

Low-Histamine Diet OTHER

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

Low-Histamine Diet

Mediterranean Diet OTHER

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

Mediterranean diet

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi

Istanbul, 34384, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Deniz ÖZÇEKER, Prof. Dr.

CONTACT

+90 532 349 8116; denizozceker@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: standard medical treatment alone, standard medical treatment plus a low-histamine diet, or standard medical treatment plus a Mediterranean diet.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: November 23, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: August 14, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)