Atopic Dermatitis (AD)
Conditions
Brief summary
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
OTHERTest formula
Partially hydrolyzed formula with synbiotics
OTHERControl formula
Intact protein formula without synbiotics
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable 2. Infant gestational age ≥ 37 completed weeks 3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg 4. Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment 5. Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled. 6. At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire 7. 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. 8. Parents/LAR must be able to provide evidence of parental authority and identity. 9. 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
1. Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes. 2. 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. 3. Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy. 4. Infant is currently participating or has previously participated in another clinical trial prior to enrollment. 5. Infant's parents or LARs have not reached legal age of majority (18 years).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TransEpidermal Water Loss (TEWL) at 3 months | At 3 months of age | TransEpidermal water loss will be measured using a validated non-invasive technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin metabolites | From enrollment to 12 months of age | Levels of skin metabolites using targeted or untargeted approaches. |
| Immune proteomics | From enrollment to 6 months of age | Levels of plasma proteins using mass cytometry or immunoassaysand immunoassays. |
| Immune blood cell immunophenotyping | From enrollment to 6 months of age | Levels of immune cell populations using mass cytometry or immunoassays |
| Cumulative incidence of Atopic Dermatitis | From enrollment to 12 months of age | Cumulative incidence of AD is based on physician diagnosis using the United Kingdom Working Party (UKWP) diagnosis criteria. |
| TransEpidermal Water Loss | From enrollment to 12 months of age | Epidermal water loss will be measured using a validated non-invasive technique. |
| Skin surface (stratum corneum) hydration | From enrollment to 12 months of age | Skin hydration will be measured with a corneometer device. |
| Extent and severity of Atopic Dermatitis | From 3 months to 12 months of age | SCORAD (SCORing for Atopic Dermatitis), scores range from 0 to 103, with higher scores indicating higher atopic dermatitis severity |
| Cumulative use of topical steroids and calcineurin inhibitors | From enrollment to 12 months of age | Use of medication to treat AD and other symptoms will be collected via parent self-reported questionnaire. |
| Skin cytokines | From enrollment to 12 months of age | Concentration of skin cytokines such as IL4 and IL5 using immunoassays |
| Skin natural moisturizing factors | From enrollment to 12 months of age | Concentration of skin natural moisturizing factors such as Pyrrolidone carboxylic acid, using HPLC |
| Skin microbiome | From enrollment to 12 months of age | Overall skin microbiome composition and diversity using next-generation sequencing |
| Specific IgE antibodies | At 12 months of age | Specific IgE antibodies will be measured using Phadiatop infant®. |
| Fecal microbiome | From enrollment to 12 months of age | Overall fecal microbiota composition, diversity, different bacteria taxa and microbiota community types assessed using next generation sequencing (NGS) technology |
| Fecal metabolites | From enrollment to 12 months of age | Levels of fecal metabolites using targeted or untargeted approaches. |
| Fecal biomarkers of inflammation and immunity | From enrollment to 12 months of age | Levels of fecal markers of immune health and inflammation such as total secretory IgA (sIgA), calprotectin, and α-1-antitrypsin assessed by ELISA. |
| Physician-diagnosed allergic manifestations | From enrollment to 12 months of age | Number of participants with Physician-diagnosed allergic manifestations. |
| Gastrointestinal tolerance | At enrollment and 4 months of age | Infant Gastrointestinal Symptom Questionnaire (IGSQ), scores range from 13 to 65, with higher scores indicating higher gastrointestinal discomfort. |
| Weight | From enrollment to 12 months of age | Weight (g and z-scores) |
| Height | From enrollment to 12 months of age | Length (cm and z-scores) |
| Head circumference | From enrollment to 12 months of age | Head circumference (cm and z-scores) |
| Safety assessment | From enrollment to 13 months of age | Incidence of adverse events |
| Skin stratum corneum lipids | From enrollment to 12 months of age | Concentration of skin stratum corneum lipids such as ceramides, cholesterol and triacylglycerol using mass spectrometry |
Countries
Belgium, France, Germany, Spain
Contacts
Primary ContactAmelie Goyer, PhD
Outcome results
None listed