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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
164
Powder based infant formula with Inulin I
Powder based infant formula with Inulin II
Powder based infant formula without Inulin
Research Unit of Indonesian Pediatrics Association
Jakarta, Indonesia
Difference between beneficial bacteria I level in stool at week 4 and week 8.
Time frame: Week 4, Week 8.
Difference between beneficial bacteria II level in stool at week 4 and week 8.
Time frame: Week 4, Week 8.
Difference between pH of stool at week 4 and week 8.
Time frame: Week 4, Week 8.
Difference between stool consistency at week 4 and week 8.
Time frame: Week 4, Week 8.
Difference between sIgA at week 4 and week 8.
Time frame: Week 4, Week 8.
Difference between SCFA at week 4 and week 8.
Time frame: Week 4, Week 8.
Safety and tolerability.
The safety and tolerability achieved by continuous recording of adverse events, including the occurrence of diarrhea and constipation.
Time frame: From date of baseline visit (day 1) until the date of visit 8 (day 56)
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