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

NCT05868408 | Recruiting

• 1 other identifier: 21.10.INF
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Difference in growth in first 4 months of life between control and experimental groups

  To demonstrate that growth from enrollment to age 4 months of infants fed experimental formula 1 (EXPL1) or experimental formula 2 (EXPL2) is non-inferior to that of infants fed control formula (CTRL). This is measured by weight gain velocity (g/day).

  From enrollment to age 4 months

• Equivalence in growth in first 4 months of life in experimental groups

  To demonstrate that growth from enrollment to age 4 months is equivalent between infants fed EXPL1 or EXPL2. This is measured by weight gain velocity (g/day).

  From enrollment to age 4 months

Secondary Outcomes (12)

• Gastrointestinal (GI) tolerance

  Enrollment and age 4, 6, and 12 months

• Stooling pattern

  Age 2 and 4 months

• Atopic dermatitis severity

  Enrollment and age 4, 6, and 12 months

• Allergy-related symptoms

  Enrollment and age 4, 6, and 12 months

• Dietary intake

  Age 6 months

Other Outcomes (4)

• Stool microbiota composition

  Age 4 months

• Stool microbiota metabolism

  Age 4 months

• Fecal peptides

  Age 4 months

Study Arms (3)

Control formula

ACTIVE COMPARATOR

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

Other: Control Formula

Experimental formula 1

EXPERIMENTAL

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

Other: Experimental Formula 1

Experimental formula 2

EXPERIMENTAL

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

Other: Experimental Formula 2

Interventions

Experimental Formula 2 OTHER

Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal

Experimental formula 2

Control Formula OTHER

Infant formula made with intact protein - minimum 1.8g protein/100kcal

Control formula

Experimental Formula 1 OTHER

Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal

Experimental formula 1

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\]), if applicable)
• Infant gestational age ≥37 completed weeks
• Infant birth weight of ≥2.5 kg and ≤4.5 kg
• Singleton birth
• Infant postnatal age ≤28 days (date of birth = day 0)
• Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (3)

National Guard Hospital

Jeddah, Saudi Arabia

RECRUITING

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

COMPLETED

National Guard Hospital

Riyadh, Saudi Arabia

ACTIVE NOT RECRUITING

Central Study Contacts

Anthony de Cozar

CONTACT

+41 21 785 8573; anthony.decozar@rd.nestle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, controlled, multi-arm trial

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 22, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (3)