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Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants | Clinical Trials | Clareo Health

RECRUITINGNA

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

Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial

NCT05868408•Société des Produits Nestlé (SPN)

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (3)

National Guard Hospital

Jeddah, Saudi Arabia

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

National Guard Hospital

Riyadh, Saudi Arabia

Key Dates

Start Date

August 17, 2023

Primary Completion Date

December 1, 2027

Completion Date

June 1, 2028

Last Updated

December 19, 2025

Enrollment

234

ESTIMATED participants

Conditions

Infant Nutritional Physiological PhenomenaInfant FormulaInfant HealthInfant DevelopmentGrowth and Development

Interventions

Control Formula

OTHER

Experimental Formula 1

OTHER

Experimental Formula 2

OTHER

Contacts

Anthony de Cozar

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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