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Идёт набор NCT07039773

Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?

Без фазы С лечением Celiac Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Vital wheat gluten, Vital wheat gluten.
Кому может быть актуально
Состояния в реестре: Celiac Disease. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Assessing Immune Responses to Gluten: A Comparative Study of Liquid Versus Solid Gluten Administration

Обзор

The goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). The main questions it aims to answer are: * Does liquid gluten administration elicit a higher IL-2 cytokine response compared to solid gluten administration? * What is the relationship between serum IL-2 levels and gluten peptide serum concentrations following gluten challenges? Researchers will compare the responses of two groups: participants receiving liquid gluten (shake) to those receiving solid gluten (cookie) to determine if there is a significant difference in the IL-2 response rates between the two forms. Participants will be asked to: * Undergo two gluten challenges (liquid and solid) in a randomized order with at least 4 weeks apart. * Provide blood samples before and after each challenge to measure serum IL-2 levels and gluten peptide concentrations over a period of 6 hours. * Report any symptoms experienced following each gluten challenge.

Вмешательства

  • Пищевая добавка Vital wheat gluten
    Gluten-containing shake vs gluten-containing cookie
  • Пищевая добавка Vital wheat gluten
    Half of participants will receive gluten-containing shake first, then gluten-containing cookie next, and vice versa

Первичные конечные точки

  • Comparison of serum IL-2 response rates between the gluten shake group and the cookie group [Срок оценки: From baseline to 4 hours at visit 1]
Вторичные конечные точки (4)
  • Correlation between serum IL-2 response levels and baseline whole blood plasma IL-2 [Срок оценки: From baseline to 6 hours after gluten intake]
  • Correlation between serum IL-2 response levels and baseline number of gluten-specific T cells [Срок оценки: From baseline to 6 hours after gluten intake]
  • Correlation between serum IL-2 response levels and symptom severity [Срок оценки: From baseline to 6 hours after gluten intake]
  • Comparison of serum IL-2 response levels and serum gluten peptide levels [Срок оценки: From baseline to 6 hours after gluten intake]

Критерии участия

Критерии включения

  • BMI 18-33 kg/m2
  • Willingness to comply with the study procedure and having signed informed, written consent
  • Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and/or IgG-DGP) (diagnosed in childhood) and a duodenal biopsy showing villous atrophy graded as Marsh 3 according to guidelines from European Society for Study of Coeliac Disease .
  • Strict adherence to a gluten-free diet at least the 12 last months.

Критерии исключения

  • Positive serology (IgA-TG2 below upper level of normal) at screening visit
  • Pregnancy or breast feeding. Fertile women must use effective contraception.
  • Other inflammatory disease like uncontrolled hypothyreosis, type 1 diabetes, cardiovascular diseases, thyroid and renal disorders, inflammatory bowel diseases or any other disease that in the opinion of the responsible clinician makes the patient unsuitable for the study
  • Using of immunosuppressive/steroid medications
  • Wheat allergy
  • Severe acute infection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Норвегия · 2 центра
  • Oslo University Hospital — Oslo
  • Lovisenberg Diakonale Hospital — Oslo

Публикации

  • Tye-Din JA, Daveson AJM, Goldstein KE, Hand HL, Neff KM, Goel G, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Patient factors influencing acute gluten reactions and cytokine release in treated coeliac disease. BMC Med. 2020 Nov 26;18(1):362. doi: 10.1186/s12916-020-01828-y. PMID 33239013
  • Goel G, Daveson AJM, Hooi CE, Tye-Din JA, Wang S, Szymczak E, Williams LJ, Dzuris JL, Neff KM, Truitt KE, Anderson RP. Serum cytokines elevated during gluten-mediated cytokine release in coeliac disease. Clin Exp Immunol. 2020 Jan;199(1):68-78. doi: 10.1111/cei.13369. Epub 2019 Oct 1. PMID 31505020

Идентификаторы

NCT: NCT07039773 · 24/27476

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗