RecruitingNot Applicable

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

Saudi Arabia234 participantsStarted 2023-08-17

Plain-language summary

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

Who can participate

Age range

0 Days – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From enrollment to age 4 months

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

Timeframe: From enrollment to age 4 months

Trial details

NCT IDNCT05868408

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Anthony de Cozar

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

View on ClinicalTrials.gov More Infant Nutritional Physiological Phenomena trials