Study on the Effect of Inulin in Infant Formula on Gut Health
NCT ID: NCT01515644
Last Updated: 2013-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
164 participants
INTERVENTIONAL
2011-10-31
2013-02-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention group I
Intervention group I: Powder based Infant formula with Inulin I
Powder based infant formula
Powder based infant formula with Inulin I
Intervention group II
Intervention group II: Powder based Infant formula with Inulin II
Powder based infant formula
Powder based infant formula with Inulin II
Intervention group III
Intervention group III: Powder based Infant formula without Inulin
Powder based infant formula
Powder based infant formula without Inulin
Interventions
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Powder based infant formula
Powder based infant formula with Inulin I
Powder based infant formula
Powder based infant formula with Inulin II
Powder based infant formula
Powder based infant formula without Inulin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Not consuming study product longer than 2 days consecutively
* Intake of study product is less than 500ml per day for 7 days
3 Months
4 Months
ALL
Yes
Sponsors
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Danone Global Research & Innovation Center
INDUSTRY
PT. Sari Husada
INDUSTRY
Responsible Party
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Principal Investigators
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Hanifah Oswari, dr., Sp.A(K), PhD
Role: PRINCIPAL_INVESTIGATOR
Research Unit of Indonesian Pediatrics Association
Locations
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Research Unit of Indonesian Pediatrics Association
Jakarta, , Indonesia
Countries
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Other Identifiers
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CT.01.2010
Identifier Type: -
Identifier Source: org_study_id
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