Effects of special infant formulas on growth and digestion in healthy babies
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial
This study tests how special baby formulas made from whey protein affect the growth and tummy comfort of healthy infants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | Société des Produits Nestlé (SPN) Industry-sponsored |
| Locations | 3 sites (Jeddah and 2 other locations) |
| Trial ID | NCT05868408 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy term infants aged 28 days or younger who are fully formula-fed and meet specific weight and gestational age criteria.
Not a fit: Infants with chronic illnesses, congenital abnormalities, or maternal conditions affecting growth may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved infant growth and digestive health through optimized formula options.
How similar studies have performed: Other studies have shown positive outcomes with similar approaches in infant nutrition, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jeddah and 2 other locations
- 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)
Study contacts
- Study coordinator: Anthony de Cozar
- Email: anthony.decozar@rd.nestle.com
- Phone: +41 21 785 8573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.