Research Unit of Indonesian Pediatrics Association
Jakarta, Indonesia
NCT Number: NCT01515644
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.
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Notify Me3 month–4 month
All sexes
Interventional
Phase 3
Jakarta, Indonesia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
at screening:
Exclusion criteria
at screening:
Exclusion criteria
for intervention period:
Powder based infant formula with Inulin I
Time frame: Week 4, Week 8.
Time frame: Week 4, Week 8.
Time frame: Week 4, Week 8.
Time frame: Week 4, Week 8.
Time frame: Week 4, Week 8.
Time frame: Week 4, Week 8.
Time frame: 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.
PT. Sari Husada
Industry
A Randomized, Double-blind, Controlled Study on the Effect of Inulin on Gut Health of Infants
Acronym: STAR-IFFO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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