Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria

NCT07765979 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-08-14

No results posted yet for this study

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

Interventions

OTHER

Low-Histamine Diet

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

OTHER

Mediterranean Diet

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

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-23
Primary Completion
2027-01-15
Completion
2027-01-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07765979 on ClinicalTrials.gov