Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

Официальное название

Synbiotics in Partially Hydrolysed Formula for Improved skiN Barrier Function in Infants at Risk for Allergy (SPHINX Study)

Обзор

The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.

Вмешательства

• Другое Test formula
  Partially hydrolyzed formula with synbiotics
• Другое Control formula
  Intact protein formula without synbiotics

Первичные конечные точки

• TransEpidermal Water Loss (TEWL) at 3 months [Срок оценки: At 3 months of age]

Вторичные конечные точки (12)

• Cumulative incidence of Atopic Dermatitis [Срок оценки: From enrollment to 12 months of age]
• TransEpidermal Water Loss [Срок оценки: From enrollment to 12 months of age]
• Skin surface (stratum corneum) hydration [Срок оценки: From enrollment to 12 months of age]
• Extent and severity of Atopic Dermatitis [Срок оценки: From 3 months to 12 months of age]
• Cumulative use of topical steroids and calcineurin inhibitors [Срок оценки: From enrollment to 12 months of age]
• Skin cytokines [Срок оценки: From enrollment to 12 months of age]
• Skin natural moisturizing factors [Срок оценки: From enrollment to 12 months of age]
• Skin stratum corneum lipids [Срок оценки: From enrollment to 12 months of age]
• Skin microbiome [Срок оценки: From enrollment to 12 months of age]
• Skin metabolites [Срок оценки: From enrollment to 12 months of age]
• Immune proteomics [Срок оценки: From enrollment to 6 months of age]
• Immune blood cell immunophenotyping [Срок оценки: From enrollment to 6 months of age]

Критерии участия

Критерии включения

• Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable
• Infant gestational age ≥ 37 completed weeks
• Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
• Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment
• Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
• At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
• a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age.

or b. For the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. The decision to introduce formula feeding was independently made by the parents before enrollment.

• Parents/LAR must be able to provide evidence of parental authority and identity.
• Infant's parent(s)/LAR must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol.

Критерии исключения

• Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.
• Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding.
• Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
• Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
• Infant's parents or LARs have not reached legal age of majority (18 years).

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Испания · 9 центров

• Hospital Teresa Herrera — A Coruña
• HU Torrecárdenas — Almería
• Hospital Quiron Salud Barcelona — Barcelona
• Hospital Universitario Severo Ochoa — Madrid
• Grupo Pediátrico Uncibay — Málaga
• Instituto Hispalense de Pediatria (IHP) — Seville
• Hospital Universitari de Tarragona Joan XXIII — Tarragona
• Hospital Universitari Sant Joan de Reus — Tarragona
• … и ещё 1 центр

Франция · 6 центров

• CHU Amiens Picardie — Amiens
• CHU de Caen — Caen
• CHU de Grenoble Alpes — Grenoble
• Hôpital de la Croix Rousse — Lyon
• Hôpital Charles Nicolle — Rouen
• CHRU de Tours — Tours

Германия · 5 центров

• Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) — Berlin
• Evangelisches Krankenhaus Düsseldorf - Frauenklinik — Düsseldorf
• Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt — Frankfurt
• Evangelisches Waldkrankenhaus Spandau — Spandau
• Marien Hospital Wesel GmbH — Wesel

Бельгия · 3 центра

• AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan — Bruges
• Universitair Ziekenhuis Brussel - Kinderziekenhuis — Brussels
• Clinique Ste Elisabeth — Namur

Польша · 2 центра

• Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny — Bialystok
• BioMedical Centers — Warsaw

Идентификаторы

NCT: NCT06943469 · 2215INF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗