Beneficial Bacteria in Gut
Conditions
Brief summary
This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.
Interventions
OTHERRegular non-hydrolysed cow's milk I
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I
OTHERRegular non-hydrolysed cow's milk II
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II
OTHERRegular non-hydrolysed cow's milk - control
Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture
Sponsors
Danone Asia Pacific Holdings Pte, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
43 Days to 65 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy term infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks) aged 46 - 65 days (inclusive) at entry into the study * 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 legal guardian's written informed consent
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group | baseline, week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group | baseline, week 6 |
| Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group | baseline, week 6 |
Countries
Thailand
Outcome results
None listed