Healthy
Conditions
Keywords
Healthy babies, Infant formula, Growth
Brief summary
To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk
Detailed description
Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.
Interventions
DIETARY_SUPPLEMENTInfant formula (CF)
Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
DIETARY_SUPPLEMENTInfant Formula (EF)
Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent signed and dated 2. Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium 3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol. 4. Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study. 5. Infants whose parent(s)/LAR have a working freezer. 6. Healthy term, singleton infant at birth. 7. At enrollment visit, post-natal age ≤ 14 days (date of birth = day 0). 8. At enrollment, birth weight ≥ 2500g and ≤ 4500g. 9. For formula-fed group, infant of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment.
Exclusion criteria
1. Infants with conditions requiring infant feedings other than those specified in the protocol. 2. Infants receiving complementary foods or liquids. 3. Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results. 4. Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results. 5. Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth | 120 days | Growth (weight gain velocity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency) | Every month up to 6 months of age | Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency) |
| GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake) | Every month up to 6 months of age | GI tolerance (3-day GI symptom and behavior diary - including GI symptoms (frequency and amount of spitting-up/vomiting, and frequency of flatulence), GI-related behaviors (duration of crying and fussiness, sleeping, and the frequency of excessive crying episodes), and milk intake) |
| Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR) | Every month up to 4 months of age | Fecal microbiota composition, diversity, and abundance |
| Growth | Every month up to 6 months of age | Other growth outcomes will be compared to the World Health Organization 2006 Growth Standards and by treatment group |
| Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing) | Up to 3 months of age | Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing) |
| Adverse events / Morbidity | 180 days | Adverse events / Morbidity |
| Fecal markers (pH, fecal organic acids, and protein markers of gut health) | Every month up to 4 months of age | Fecal markers (pH, fecal organic acids, and protein markers of gut health) |
Countries
Belgium, Italy
Outcome results
None listed