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Pseudoallergen-Free and Low-Histamine Diet in Adolescents With Chronic Spontaneous Urticaria

NCT07632040 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-08

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether a histamine- and pseudoallergen-restricted diet can help reduce symptoms in people with chronic urticaria. It will also learn whether this diet changes the need for urticaria medication.

The main questions it aims to answer are:

Does the diet lower urticaria activity, including hives and itching?

Does the diet improve disease control and quality of life?

Does the diet change the need for urticaria medication?

Which clinical or laboratory factors may affect response to the diet?

There is no comparison group. Researchers will compare participants' symptoms before and after the diet.

Participants will:

Follow a structured histamine- and pseudoallergen-restricted diet

Continue their usual urticaria treatment as recommended by their doctor

Record or report their urticaria symptoms during follow-up

Visit the clinic for assessment of symptoms, disease control, quality of life, medication use, and laboratory findings.

Conditions

  • Pediatric Chronic Spontaneous Urticaria

Interventions

BEHAVIORAL

Intervention Name: Low-histamine and pseudoallergen-free diet

Participants assigned to the intervention group will receive a structured low-histamine and pseudoallergen-free diet for 4 weeks in addition to standard guideline-based clinical care. The diet will restrict histamine-rich foods, foods considered to promote histamine release, and foods containing common pseudoallergen sources such as selected additives, preservatives, colorants, and naturally occurring pseudoallergen-rich foods. Antihistamine treatment will be permitted according to clinical need.

BEHAVIORAL

General healthy eating advice

Participants assigned to the control group will receive standard guideline-based clinical care together with general age-appropriate healthy eating advice. No specific restriction of histamine-rich foods, histamine-releasing foods, or pseudoallergen-containing foods will be recommended during the primary 4-week comparison period. Antihistamine treatment will be permitted according to clinical need.

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2026-11-24
Completion
2027-01-31

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 NCT07632040 on ClinicalTrials.gov