Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function (SPHINX)

Nestlé

Status: Enrolling

Conditions: Atopic Dermatitis (AD)

Treatments: Other: Control formula; Other: Test formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT06943469

2215INF

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 to 14 days old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

400 participants in 3 patient groups

Test formula

Experimental group

Description:

Partially hydrolyzed formula with synbiotics

Treatment:

Other: Test formula

Control formula

Active Comparator group

Description:

Intact protein formula without synbiotics

Treatment:

Other: Control formula

Reference arm

No Intervention group

Description:

Breastfed arm (not applicable for France)