Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

Société des Produits Nestlé (SPN)400 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

400

Conditions

Atopic Dermatitis (AD)

Interventions

Test formulaOTHER

Partially hydrolyzed formula with synbiotics

Control formulaOTHER

Intact protein formula without synbiotics

Eligibility

Sex: ALLMin age: 1 DayMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (25)

AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan

Bruges, Belgium

Outcomes

Primary Outcomes

TransEpidermal Water Loss (TEWL) at 3 months

TransEpidermal water loss will be measured using a validated non-invasive technique.

Time frame: At 3 months of age

Secondary Outcomes

Cumulative incidence of Atopic Dermatitis

Cumulative incidence of AD is based on physician diagnosis using the United Kingdom Working Party (UKWP) diagnosis criteria.