Status:
COMPLETED
Study on the Effect of Inulin in Infant Formula on Gut Health
Lead Sponsor:
PT. Sari Husada
Collaborating Sponsors:
Danone Global Research & Innovation Center
Conditions:
Healthy Infants
Eligibility:
All Genders
3-4 years
Phase:
PHASE3
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 Infa...
Eligibility Criteria
Inclusion
- 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.
- Exclusion criteria for intervention period:
- Not consuming study product longer than 2 days consecutively
- Intake of study product is less than 500ml per day for 7 days
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT01515644
Start Date
October 1 2011
End Date
February 1 2013
Last Update
April 24 2013
Active Locations (1)
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1
Research Unit of Indonesian Pediatrics Association
Jakarta, Indonesia