healthy infants
Conditions
Interventions
Duration of intervention: 6 months.
Intervention group 1: Healthy infants receiving a standard cow’s milk-based infant formula containing a combination of two known immunologically active ingredients
Sponsors
Danone Research - Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy term infants (gestational age 37 to 42 weeks); 2. Birth weight within normal range for gestational age and sex (10th to 90th percentile according to applicable growth charts); 3. Age ≤ 7 days at baseline; 4. For infants to be randomised into one of the formula groups: Infants who are fully formula-fed or have started the transition from breast- to formula-feeding (indicated by the feeding of at least one bottle of infant formula in the past); 5. For infants to be recruited into the breast-fed reference group: Infants who are exclusively breast-fed since birth (never received any infant formula) and with the mother's intention to continue exclusive breast-feeding until the infant's age of at least 4 months; 6. Written informed consent from both parents; 7. Parents' willingness and ability to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Infants whose mothers are known to suffer from hepatitis B, Human Immunodeficiency Virus (HIV) or Group B Streptococcal infection (GBS); 2. Infants whose mothers have taken antibiotics while breast-feeding; 3. Infants having received antibiotics prior to participation in the study; 4. Current or previous illnesses which could interfere with the study (e.g. prolonged severe diarrhoea); 5. Known congenital diseases or malformations which could interfere with the study (gastrointestinal malformations, congenital immunodeficiency); 6. High risk to develop an atopic disease (at least one parent or sibling with manifest atopic symptoms of hay fever, asthma or atopic dermatitis); 7. Need to feed a special diet other than standard cow's milk-based IF; 8. Study pre-feedings which could interfere with the study, e.g. non-cow's milk-based formulas, HA formulas, probiotic formulas.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To investigate the effects on the composition and metabolic activity of the intestinal microbiota (e.g. percentage of bifidobacteria and potential pathogens, pH and short-chain fatty acids) and on the immune status (e.g. SIgA) in healthy term infants during the first 6 months of life of: A. An IF containing immunologically active ingredient 1 and/or immunologically active ingredient 2 compared to a standard IF; B. The three investigational formulas compared with each other. 2. To assess intestinal tolerance and safety of an infant formula containing immunologically active ingredient 1 and/or immunologically active ingredient 2; 3. As reference, to assess the composition and metabolic activity of the intestinal microbiota (e.g. percentage of bifidobacteria and potential pathogens, pH and short-chain fatty acids) and on the immune status (e.g. SIgA) in healthy term exclusively breast-fed infants during the first 6 months of life. | — |
Contacts
Public ContactJenny Cadée
P.O. Box 7005
Outcome results
None listed