Effects of special infant formulas on growth and digestion in healthy babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how partially hydrolyzed, whey-based infant formulas impact growth and gastrointestinal tolerance in healthy term infants. The research involves administering different formulas to assess their effects on infant development and comfort. Eligible infants will be monitored for growth metrics and any gastrointestinal issues over a specified period. The study aims to provide insights into the nutritional needs of infants who are formula-fed.

Why it matters

Who can join: the full rules

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. For Saudi: Infant postnatal age ≤28 days (date of birth = day 0); For Philippines: Infant postnatal age ≥ 14 days and ≤ 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

Where it's running

• Biomedical Research Institute
  Cavite City, Philippines Recruiting
• Biomedical Research Institute
  Las Piñas, Philippines Recruiting
• National Guard Hospital
  Jeddah, Saudi Arabia Active not recruiting
• King Faisal Specialist Hospital and Research Center
  Riyadh, Saudi Arabia Completed
• National Guard Hospital
  Riyadh, Saudi Arabia Completed

Study contacts

• Study coordinator: Qiaoji Li
• Email: qiaoji.li@rd.nestle.com
• Phone: +861087419794

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.