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Набор скоро начнётся NCT07711938

Growth And Safety Outcomes In Infants With Cow´s Milk Protein Allergy (CMPA) Fed A Novel Extensively Hydrolyzed Formula (eHF)

Без фазы С лечением Cow Milk Protein Allergy

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: New generation eHF, Commercial eHF.
Кому может быть актуально
Состояния в реестре: Cow Milk Protein Allergy. Базовые параметры: 29 Days — 22 Weeks · 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
Список центров уточняется — проверьте первичный протокол.
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

A Randomized, Double-Blind, Controlled Study to Compare Growth, Tolerability, and Safety of a Novel, Extensively Hydrolyzed Formula (eHF) Versus a Standard eHF in Full Term Infants With Cow's Milk Protein Allergy (CMPA)

Обзор

Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.

Вмешательства

  • Пищевая добавка New generation eHF
    New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.
  • Пищевая добавка Commercial eHF
    Commercial whey-based eHF formula intended for the dietary management of infants with CMPA.

Первичные конечные точки

  • Weight Gain Over 16 Weeks [Срок оценки: 16 weeks]
Вторичные конечные точки (12)
  • Incidence of Adverse Events of Special Interest (AESIs) [Срок оценки: 52 weeks]
  • Growth Parameters: Weight [Срок оценки: 52 weeks]
  • Growth Parameters: Length [Срок оценки: 52 weeks]
  • Quality of Life Scores (ITQOL) [Срок оценки: 52 weeks]
  • Stool Frequency and Stool Characteristics (BITSS) [Срок оценки: 52 weeks]
  • Resolution of CMPA-Related Symptoms [Срок оценки: 52 weeks]
  • Formula intake compliance [Срок оценки: 52 weeks]
  • Healthcare resources utilization [Срок оценки: 52 weeks]
  • Growth Parameters: Head Circumference [Срок оценки: 52 weeks]
  • Quality of Life Scores (FLIP) [Срок оценки: 52 weeks]
  • Resolution of Cow Milk Protein Allergy (CMPA)-Related Symptoms [Срок оценки: 52 weeks]
  • Resolution of CMPA-Related Symptoms [Срок оценки: 52 weeks]

Критерии участия

Критерии включения

  • Full-term infant(gestational age ≥37 weeks and ≤42 weeks).
  • Birth weight ≥2500 g and ≤4500 g.
  • Parent(s)/LAR deemed able to provide written informed consent for participation of their infant in the study (in the opinion of the investigator).
  • Participant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks) at time of enrollment.
  • Not breastfed at time of Screening Visit.
  • History of an immediate-type (IgE-mediated) allergic reaction to a cow's milk-containing food or at least 2 persistent severe symptoms suggestive of delayed-onset (non-IgE-mediated) CMPA.

Критерии исключения

  • Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
  • Congenital illness or malformation that may affect growth, or significant pre-natal and/or serious post-natal disease other than CMPA before randomization (per investigator's medical decision).
  • Demonstrated chronic malabsorption not due to CMPA.
  • History of severe anaphylaxis to CMP.
  • Infants whose parent(s)/LAR cannot be expected to comply with study procedures.
  • Currently participating or having participated in another clinical study since birth.
  • Infants with a history of confirmed food protein induced enterocolitis syndrome due to other foods than CMP or Heiner syndrome.
  • Infants with history of oral immunotherapy for CMPA.
  • Diagnosed eosinophilic esophagitis.
  • Received systemic oral or injected corticosteroids for more than 3 days (72 hours) within 2 weeks prior to the Screening Visit (topical corticosteroids allowed).
  • Received systemic antibiotics within 1 week prior to Screening Visit (topical antibiotics, e.g., mupirocin allowed).
  • Infants who are currently receiving treatment with immunomodulators (immunoglobulins, allergen extracts, or similar) or immuno-suppressants (azathioprine, cyclosporine or similar) within 2 weeks of Screening Visit (topical cyclosporine, tacrolimus, pimecrolimus or similar topical eczema treatments allowed), as well as infants with immune disorders which can compromise the immune function.
  • Infants with a past or current disease or disorder which, in the opinion of the investigator or the sponsor either places the participant at risk because of participating in the study or may influence the results of the study, or the participant's ability to participate in the study (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine or metabolic disorders, malignancy, major physical impairment, immunodeficiency, infectious disease or abnormal laboratory results as per the investigator's judgment).
  • Parent(s)/LAR being in any relationship or dependency with the sponsor, and/or the investigator, and/or study staff.
  • Underage parents (under 18 years old).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07711938 · 2508.CLI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗