Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

Spain · 9 centers

• 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
• … and 1 more center

France · 6 centers

• 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

Germany · 5 centers

• 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

Belgium · 3 centers

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

Poland · 2 centers

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

Identifiers

NCT: NCT06943469 · 2215INF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗