Evaluating the effects of a special infant formula on growth and infections in babies
A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula and a follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections in Healthy Term Infants
This study tests if a special infant formula with added ingredients can help healthy babies grow better and get fewer infections compared to a regular formula.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 456 (estimated) |
| Ages | 5 Days to 60 Days |
| Sex | All |
| Sponsor | FrieslandCampina Industry-sponsored |
| Locations | 3 sites (Athens and 2 other locations) |
| Trial ID | NCT06137235 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the growth, product tolerance, and infection-related symptoms in healthy infants consuming an infant formula and follow-on formula that contain bio-active ingredients. The study compares these infants to a control group receiving a standard formula. A total of 456 healthy term infants, aged less than 2 months and exclusively formula-fed, will be monitored until they reach 1 year of age. The trial aims to determine if the bio-active ingredients improve health outcomes compared to standard formulas.
Who should consider this trial
Good fit: Ideal candidates are healthy, full-term infants aged less than 2 months who are exclusively formula-fed.
Not a fit: Infants with severe diseases, allergies, or intolerances that affect study outcomes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved growth and reduced infections in infants through enhanced nutrition.
How similar studies have performed: Other studies have shown promising results with bio-active ingredients in infant nutrition, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Full-term infants * Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g * Boys and girls * Apparently healthy at birth and screening * Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards * Age at enrolment: ≤60 days of age * If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion * If 1 month \< age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2 * Being available for follow up until the age of 12 months * Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years Exclusion Criteria: * Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID)) * Incapability of parents to comply with the study protocol * Illiterate parents (i.e. not able to read and write in local language) * Participation in another clinical trial * Unwillingness to accept the formula supplied by the study as the only formula for their child until the age of 12 months * Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion
Where this trial is running
Athens and 2 other locations
- Harokopio University — Athens, Greece (Recruiting)
- International Hellenic University — Thessaloníki, Greece (Recruiting)
- University of Thessaly — Tríkala, Greece (Recruiting)
Study contacts
- Principal investigator: Yannis Manios, Prof — Harokopio University
- Study coordinator: Mirre Viskaal, PhD
- Email: mirre.viskaal@frieslandcampina.com
- Phone: +31646911358
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.