AzTrials
AzTrials

Pediatric Chronic Spontaneous UrticariaPAF-LH-CSUNCT07632040

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

A study testing Intervention Name: Low-histamine and pseudoallergen-free diet and General healthy eating advice in people with Pediatric Chronic Spontaneous Urticaria, run by Istanbul University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Pediatric Chronic Spontaneous Urticaria
What is being tested?
Intervention Name: Low-histamine and pseudoallergen-free diet and General healthy eating advice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Nov 2025to 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 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

None listed.

Who cannot join

  • Pure chronic inducible urticaria Urticaria secondary to an identified trigger IgE-mediated food allergy requiring a specific elimination diet Active infection or parasitic disease Oral corticosteroid use within the previous 4 weeks Current or recent biological treatment for chronic urticaria Coeliac disease Inflammatory bowel disease Known systemic mast cell disease Severe chronic systemic disease affecting diet, growth, or follow-up Significant malnutrition or a medical condition requiring a special diet Pregnancy or lactation in postmenarchal adolescents Inability or unwillingness of the child or family to adhere to the assigned dietary recommendation Incomplete follow-up data

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
  • Istanbul University, Istanbul Faculty of Medicine, Department of Pediatric Allergy and Immunology

    Istanbul, Fatih, 34100

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical Response to a Histamine- and Pseudoallergen-Restricted Diet in Patients With Chronic Urticaria

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:

Read more

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.

Read the detailed description

Chronic spontaneous urticaria in children is a heterogeneous condition characterized by recurrent wheals, angioedema, or both for more than six weeks without a consistent external trigger. Although second-generation H1-antihistamines are the mainstay of treatment, disease activity may persist in some children despite standard care.

Dietary factors, including histamine-rich foods, histamine-releasing foods, and pseudoallergens such as selected additives, preservatives, colorants, and naturally occurring food components, have been proposed as potential aggravating factors in a subset of patients. However, the clinical value of dietary restriction in pediatric chronic spontaneous urticaria remains uncertain, and better evidence is needed to determine whether a time-limited dietary approach provides additional benefit.

This randomized controlled study will evaluate a structured low-histamine and pseudoallergen-free diet as an adjunct to standard guideline-based care in children with chronic spontaneous urticaria. The comparator group will receive standard care with general age-appropriate healthy eating advice, without specific restriction of histamine-rich or pseudoallergen-containing foods during the primary comparison period.

All participants will continue to receive standard clinical care according to current urticaria management principles. Antihistamine treatment will be permitted according to clinical need. The study will also explore whether baseline clinical and laboratory characteristics, including autologous serum skin test status and routine inflammatory markers, are associated with response to the dietary intervention.

Because this is a pediatric dietary study, the dietary intervention will be standardized, time-limited, and implemented with parental guidance. Unnecessary prolonged dietary restriction will be avoided.

Being tested
Intervention Name: Low-histamine and pseudoallergen-free diet, General healthy eating advice
Keywords
low-histamine diet, pseudoallergen-free diet, urticaria control test, UAS7, autologous serum skin test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention Name: Low-histamine and pseudoallergen-free dietBehavioural

    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.

  • General healthy eating adviceBehavioural

    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.

Study groups in NCT07632040
Study groupRoleWhat they receive
Low-histamine and pseudoallergen-free diet groupExperimentalChildren with chronic spontaneous urticaria assigned to this arm will receive a structured low-histamine and pseudoallergen-free diet in addition to standard guideline-based clinical care.
Receives: Behavioral: Intervention Name: Low-histamine and pseudoallergen-free diet
General dietary advice control groupActive comparatorChildren with chronic spontaneous urticaria assigned to this arm will receive standard guideline-based clinical care with general age-appropriate healthy eating advice, without specific restriction of histamine-rich or pseudoallergen-containing foods during the primary comparison period.
Receives: Behavioral: General healthy eating advice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weekly urticaria activity score

    Change in weekly urticaria activity score (UAS7) from baseline to week 4 will be compared between the low-histamine and pseudoallergen-free diet group and the general healthy eating advice control group.

    Measured: Baseline to week 4

  2. Change in urticaria control test score

    Change in urticaria control test (UCT) score from baseline to week 4 will be compared between the low-histamine and pseudoallergen-free diet group and the general healthy eating advice control group.

    Measured: Baseline to week 4

Secondary outcomes (4)
  1. Change in dermatology quality-of-life score

    Change in age-appropriate dermatology quality-of-life score from baseline to week 4 will be compared between the low-histamine and pseudoallergen-free diet group and the general healthy eating advice control group.

    Measured: Baseline to week 4

  2. Change in antihistamine requirement

    Change in antihistamine requirement from baseline to week 4 will be compared between the two study groups. Antihistamine use will be assessed according to the need for standard-dose or increased-dose second-generation H1-antihistamine treatment.

    Measured: Baseline to week 4

  3. Proportion of participants achieving clinical response

    The proportion of participants achieving clinical response at week 4 will be compared between the two study groups. Clinical response will be defined as at least a 50% reduction in weekly urticaria activity score from baseline to week 4.

    Measured: Baseline to week 4

  4. Dietary adherence

    Adherence to the assigned dietary recommendation will be assessed during the 4-week intervention period using a dietary adherence checklist or dietary diary.

    Measured: Basaline to week 4.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study start24 Nov 2025
  3. Primary completion24 Nov 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07632040
Sponsor's protocol ID
ASST-PAF-LH-CSU-2025-3729877
Other IDs
2025-3729877, 2025
Acronym
PAF-LH-CSU
Status last verified
Jun 2026
First submitted
2 Jun 2026
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly shared because of privacy and ethical restrictions related to pediatric clinical data. De-identified data may be considered upon reasonable request and subject to approval by the study investigators and relevant institutional authorities.

Publications

  • Zuberbier T, Abdul Latiff AH, Abuzakouk M, Aquilina S, Asero R, Baker D, Ballmer-Weber B, Bangert C, Ben-Shoshan M, Bernstein JA, Bindslev-Jensen C, Brockow K, Brzoza Z, Chong Neto HJ, Church MK, Criado PR, Danilycheva IV, Dressler C, Ensina LF, Fonacier L, Gaskins M, Gaspar K, Gelincik A, Gimenez-Arnau A, Godse K, Goncalo M, Grattan C, Grosber M, Hamelmann E, Hebert J, Hide M, Kaplan A, Kapp A, Kessel A, Kocaturk E, Kulthanan K, Larenas-Linnemann D, Lauerma A, Leslie TA, Magerl M, Makris M, Meshkova RY, Metz M, Micallef D, Mortz CG, Nast A, Oude-Elberink H, Pawankar R, Pigatto PD, Ratti Sisa H, Rojo Gutierrez MI, Saini SS, Schmid-Grendelmeier P, Sekerel BE, Siebenhaar F, Siiskonen H, Soria A, Staubach-Renz P, Stingeni L, Sussman G, Szegedi A, Thomsen SF, Vadasz Z, Vestergaard C, Wedi B, Zhao Z, Maurer M. The international EAACI/GA(2)LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022 Mar;77(3):734-766. doi: 10.1111/all.15090. Epub 2021 Oct 20.

    PubMed 34536239
  • Weller K, Groffik A, Church MK, Hawro T, Krause K, Metz M, Martus P, Casale TB, Staubach P, Maurer M. Development and validation of the Urticaria Control Test: a patient-reported outcome instrument for assessing urticaria control. J Allergy Clin Immunol. 2014 May;133(5):1365-72, 1372.e1-6. doi: 10.1016/j.jaci.2013.12.1076. Epub 2014 Feb 9.

    PubMed 24522090
  • Mlynek A, Zalewska-Janowska A, Martus P, Staubach P, Zuberbier T, Maurer M. How to assess disease activity in patients with chronic urticaria? Allergy. 2008 Jun;63(6):777-80. doi: 10.1111/j.1398-9995.2008.01726.x.

    PubMed 18445192
  • Magerl M, Pisarevskaja D, Scheufele R, Zuberbier T, Maurer M. Effects of a pseudoallergen-free diet on chronic spontaneous urticaria: a prospective trial. Allergy. 2010 Jan;65(1):78-83. doi: 10.1111/j.1398-9995.2009.02130.x. Epub 2009 Oct 1.

    PubMed 19796222
  • Kapat A, Murmu R, Mandal S, Biswas K, Sarma N, Bala AK. Effect of Dietary Intervention in Paediatric Patients with Chronic Spontaneous Urticaria: Open Labelled Randomised Controlled Trial. Maedica (Bucur). 2025 Jun;20(2):275-282. doi: 10.26574/maedica.2025.20.2.275.

    PubMed 40880715

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Name: Low-histamine and pseudoallergen-free diet and General healthy eating advice in people with Pediatric Chronic Spontaneous Urticaria, run by Istanbul University 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 0 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 8 Jun 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weekly urticaria activity score (time frame: Baseline to week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07632040, which also lists 5 linked publications.

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 8 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in