Healthy Infants
Conditions
Keywords
Healthy infants, Infant formula, Prebiotics
Brief summary
In this study the effect of Infant formula with added Inulin will be compared with the effect of Infant formula without Inulin on the Bifidobacterium level in stool. It is expected that drinking Infant formula with added Inulin will result in higher beneficial bacteria level in stool compared to an Infant formula without Inulin.
Interventions
OTHERPowder based infant formula
Powder based infant formula with Inulin I
Sponsors
Danone Global Research & Innovation Center
PT. Sari Husada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 4 Months
Healthy volunteers
Yes
Inclusion criteria
at screening: * Healthy infants between 3-4 months (91-120 days after birth) of age at day 1 of the study, with healthy growth determined based on WHO standard * Fully formula-fed in the 28 days prior to inclusion * Expected investigational product intake of min 500ml per day * Written informed consent from the parents
Exclusion criteria
at screening: * Low birth weight (LBW) less than 2,000g. * Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required) * Use of systemic antibiotics or antimycotics medication in the 14 days prior to the study * Significant congenital abnormality that will interfere with the study objectives in the opinion of the investigator. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between beneficial bacteria I level in stool at week 4 and week 8. | Week 4, Week 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between pH of stool at week 4 and week 8. | Week 4, Week 8. | — |
| Difference between stool consistency at week 4 and week 8. | Week 4, Week 8. | — |
| Difference between beneficial bacteria II level in stool at week 4 and week 8. | Week 4, Week 8. | — |
| Difference between SCFA at week 4 and week 8. | Week 4, Week 8. | — |
| Safety and tolerability. | From date of baseline visit (day 1) until the date of visit 8 (day 56) | The safety and tolerability achieved by continuous recording of adverse events, including the occurrence of diarrhea and constipation. |
| Difference between sIgA at week 4 and week 8. | Week 4, Week 8. | — |
Countries
Indonesia
Outcome results
None listed