Exploratory study to investigate the effects of a new infant formula in healthy term infants during the first 6 months of life.
Completed
- Conditions
- healthy infants
- Registration Number
- NL-OMON20946
- Lead Sponsor
- Danone Research - Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 350
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);
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br /><br>A. An IF containing immunologically active ingredient 1 and/or immunologically active ingredient 2 compared to a standard IF;<br /><br>B. The three investigational formulas compared with each other.<br /><br>2. To assess intestinal tolerance and safety of an infant formula containing immunologically active ingredient 1 and/or immunologically active ingredient 2;<br /><br>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.
- Secondary Outcome Measures
Name Time Method