Healthy Infants
Conditions
Keywords
Healthy infants, Infant formula, Prebiotics oligosaccharides, Colonisation Resistance, Gut Microbiota
Brief summary
This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.
Interventions
OTHERRegular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I
Sponsors
Danone Global Research & Innovation Center
Danone Asia Pacific Holdings Pte, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 10 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion * Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study) * Parents' or guardian's written informed consent
Exclusion criteria
* Being weaned before inclusion (introduction of any other foods other than formula or breast milk.) * Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards * Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps) * Significant congenital abnormality that could affect the study results * Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study * Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements * Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study * Gastroenteritis in the last two weeks before inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota composition and its metabolic activity | Week 6 | * Gut microbiota composition: count and/or proportion and/or prevalence of group/genus/species of bacteria in the gut * Metabolic activity of the gut microbiota: pH, SCFA, lactate |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal symptoms (incidence and severity) | Week 1, Week 3, Week 6, Week 8 |
| Anthropometry | Week 1, Week 3, Week 6, Week 8 |
| Number, type and severity of (serious) adverse events | Week 1, Week 3, Week 6, Week 8 |
Countries
Thailand
Outcome results
None listed