Urticaria ChronicNCT07765979
Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria
A study testing Low-Histamine Diet and Mediterranean Diet in people with Urticaria Chronic, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Urticaria Chronic
- What is being tested?
- Low-Histamine Diet and Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Nov 2025to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
Istanbul, Istanbul, 34384
Deniz ÖZÇEKER, Prof. Dr., +90 532 349 8116, denizozceker@gmail.com
Deniz Özçeker, md
About this study
Official title: The Effects of the Mediterranean and Low-Histamine Diets on Disease Severity in Pediatric Chronic Spontaneous Urticaria
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.
Read the detailed description
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.
- Conditions
- Urticaria Chronic
- Being tested
- Low-Histamine Diet, Mediterranean Diet
- Keywords
- Chronic Urticaria, Mediterranean Diet, diet, histamine, Adolescent
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Histamine DietOther
Participants assigned to this intervention will receive a low-histamine diet in addition to standard medical treatment for 4 weeks.
Mediterranean DietOther
Participants assigned to this intervention will receive a Mediterranean diet in addition to standard medical treatment for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Low-Histamine Diet |
| Mediterranean diet | Experimental | Participants receive a Mediterranean diet in addition to standard medical treatment. Receives: Other: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (Day 0), Week 4, and Week 8
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0), Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start23 Nov 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urticaria ChronicStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765979
- Sponsor's protocol ID
- SBU-DYT-MGT-01
- Status last verified
- Oct 2025
- First submitted
- 10 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Mediterranean and Low-Histamine Diets on Disease Severity in Pediatric Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT07765979
- Acronym / sponsor ID
- SBU-DYT-MGT-01
- Conditions
- Urticaria Chronic
- Keywords
- Chronic Urticaria, Mediterranean Diet, diet, histamine, Adolescent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 23 Nov 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants receive standard medical treatment only without any dietary intervention. |
| Low-Histamine Diet | Experimental | Other: Low-Histamine DietParticipants receive a low-histamine diet in addition to standard medical treatment. |
| Mediterranean diet | Experimental | Other: Mediterranean DietParticipants receive a Mediterranean diet in addition to standard medical treatment. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Histamine DietParticipants assigned to this intervention will receive a low-histamine diet in addition to standard medical treatment for 4 weeks. | Other | Low-Histamine Diet |
| Mediterranean DietParticipants assigned to this intervention will receive a Mediterranean diet in addition to standard medical treatment for 4 weeks. | Other | Mediterranean diet |
Primary outcome
Urticaria Activity Score (UAS7)
Time frame: Baseline (Day 0), Week 4, and Week 8
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).
4 secondary outcomes
Urticaria Control Test (UCT)
Time frame: Baseline (Day 0), Week 4, and Week 8
Dermatology Life Quality Index (CDLQI/DLQI)
Time frame: Baseline (Day 0), Week 4, and Week 8
Diet adherence
Time frame: Weeks 2, 3, 4 and Week 8
KIDMED Index
Time frame: Baseline (Day 0), Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Histamine Diet and Mediterranean Diet in people with Urticaria Chronic, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deniz ÖZÇEKER, Prof. Dr. (+90 532 349 8116, denizozceker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urticaria Activity Score (UAS7) (time frame: Baseline (Day 0), Week 4, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.