Pseudoallergen-Free and Low-Histamine Diet in Adolescents With Chronic Spontaneous Urticaria (PAF-LH-CSU)
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:
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Fatih
-
Istanbul, Fatih, Turcja (Türkiye), 34100
- Istanbul University, Istanbul Faculty of Medicine, Department of Pediatric Allergy and Immunology
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
IInclusion Criteria:
Children aged 1 to 18 years Diagnosis of chronic spontaneous urticaria Disease duration of at least 6 weeks Presence of active urticaria symptoms at enrollment Ability of the child and/or parent/caregiver to complete symptom and diet follow-up forms Ability and willingness of the family to follow the assigned dietary recommendation Written informed consent from parent or legal guardian Assent from the child when applicable
Exclusion Criteria:
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Low-histamine and pseudoallergen-free diet group
Children 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.
|
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.
|
|
Aktywny komparator: General dietary advice control group
Children 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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in weekly urticaria activity score
Ramy czasowe: Baseline to week 4
|
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.
|
Baseline to week 4
|
|
Change in urticaria control test score
Ramy czasowe: Baseline to week 4
|
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.
|
Baseline to week 4
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in dermatology quality-of-life score
Ramy czasowe: Baseline to week 4
|
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.
|
Baseline to week 4
|
|
Change in antihistamine requirement
Ramy czasowe: Baseline to week 4
|
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.
|
Baseline to week 4
|
|
Proportion of participants achieving clinical response
Ramy czasowe: Baseline to week 4
|
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.
|
Baseline to week 4
|
|
Dietary adherence
Ramy czasowe: Basaline to week 4.
|
Adherence to the assigned dietary recommendation will be assessed during the 4-week intervention period using a dietary adherence checklist or dietary diary.
|
Basaline to week 4.
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- ASST-PAF-LH-CSU-2025-3729877
- 2025-3729877 (Inny identyfikator: Istanbul University, Istanbul Faculty of Medicine Clinical Research Ethics Committee)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .