NCT05868408 Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
| NCT ID | NCT05868408 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Société des Produits Nestlé (SPN) |
| Condition | Infant Nutritional Physiological Phenomena |
| Study Type | INTERVENTIONAL |
| Enrollment | 234 participants |
| Start Date | 2023-08-17 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 234 participants in total. It began in 2023-08-17 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
Eligibility 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. 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05868408 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 28 Days, studying Infant Nutritional Physiological Phenomena. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05868408 currently recruiting?
Yes, NCT05868408 is actively recruiting participants. Contact the research team at qiaoji.li@rd.nestle.com for enrollment information.
Where is the NCT05868408 trial being conducted?
This trial is being conducted at Cavite City, Philippines, Las Piñas, Philippines, Jeddah, Saudi Arabia, Riyadh, Saudi Arabia and 1 additional location.
Who is sponsoring the NCT05868408 clinical trial?
NCT05868408 is sponsored by Société des Produits Nestlé (SPN). The trial plans to enroll 234 participants.