Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants

Nestlé

Status: Enrolling

Conditions: Infant Nutritional Physiological Phenomena; Infant Health; Growth and Development; Infant Formula; Infant Development

Treatments: Other: Experimental Formula 1; Other: Experimental Formula 2; Other: Control Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT05868408

21.10.INF

Details and patient eligibility

About

This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.

Enrollment: 234 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Written informed consent has been obtained from at least one parent (or other 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. Singleton birth
5. Infant postnatal age ≤28 days (date of birth = day 0)
6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
7. Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol

Exclusion criteria

1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
4. Infants with special dietary needs other than standard infant formula
5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet
6. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
7. Currently participating or having participated in another interventional clinical trial prior to enrollment

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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234 participants in 3 patient groups

Control formula

Active Comparator group

Description:

CTRL, an infant formula with minimum protein content of 1.8g intact protein/100kcal

Treatment:

Other: Control Formula

Experimental formula 1

Experimental group

Description:

EXPL1, an infant formula with minimum protein content of 1.9g hydrolyzed protein/100kcal

Treatment:

Other: Experimental Formula 1

Experimental formula 2

Experimental group

Description:

EXPL2, an infant formula identical to EXPL1 but manufactured using a different partially hydrolyzed milk protein base

Treatment:

Other: Experimental Formula 2