Infant Formula in Infants and Children With Cow's Milk Allergy

Официальное название

Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy

Обзор

This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

Вмешательства

• Другое Experimental Extensively Hydrolyzed Formula
  Experimental powder formula
• Другое Placebo Extensively Hydrolyzed Formula
  Placebo powder formula

Первичные конечные точки

• Food Challenge Reactions [Срок оценки: Food Challenge 1 to Food Challenge 2 (within 14 days of the Food Challenge 1) (followed by 7 days of feeding the experimental formula at home.)]

Вторичные конечные точки (5)

• Volume of Experimental Formula Intake [Срок оценки: Home Feeding Day 1 to Day 7]
• Food Intake during Study [Срок оценки: Home Feeding Day 1 to Day 7]
• Gastrointestinal Symptoms [Срок оценки: Home Feeding Day 1 to Day 7]
• Medication Use [Срок оценки: Home Feeding Day 1 to Day 7]
• Food Challenge Positive Reactions [Срок оценки: Home Feeding Day 1 to Day 7]

Критерии участия

Критерии включения

• Participant's parent(s) is/are willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:

• Physician diagnosis of IgE-mediated CMA, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms or angioedema) AND, detectable serum milk-specific IgE >0.7 kUᴀ/L or positive skin prick test wheal ≥5 mm;
• Documentation of milk-specific serum IgE ≥15 kUᴀ/L or ≥ 5 kUᴀ/L if younger than 1 year;
• Documented cow's milk skin prick test wheal ≥8mm;
• Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
• Participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days prior to confirmation of diagnosis and food challenges.
• Participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment.
• Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
• Participant is between 3 months and 12 years of age at enrollment.
• Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Критерии исключения

• Participant is partially or exclusively breastfed at the time of enrollment.
• Participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula.
• Significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases, or abnormalities other than CMA, immunodeficiencies, unstable asthma, eczema and/or food allergies treated with biologics (omalizumab or other monoclonal antibody), FPIES, eosinophilic esophagitis, and severe uncontrolled eczema.
• Previous severe anaphylactic reaction to cow's milk within the last two years.,
• An adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test.
• Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent.
• Participant is consuming baked milk products.
• Use of and/or changing dose of high potency steroids.
• Participant is treated with any oral immunotherapy (sublingual, subcutaneous, and epicutaneous) for any food allergy.

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

Четверное слепое

Основная цель

Другое

Центры проведения

США · 9 центров

• Phoenix Children's — Phoenix
• Children's Hospital Colorado — Aurora
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
• University of Michigan Food Allergy Clinic — Ann Arbor
• University of North Carolina at Chapel Hill — Chapel Hill
• Cincinnati Children's Hospital Medical Center — Cincinnati
• Cleveland Clinic — Cleveland
• Nationwide Children's Hospital — Columbus
• … и ещё 1 центр

Идентификаторы

NCT: NCT06456541 · AL60

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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