Clinical trial NCT01515644: Study on the Effect of Inulin in Infant Formula on Gut Health
Official title: A Randomized, Double-blind, Controlled Study on the Effect of Inulin on Gut Health of Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Infants
Keywords: Healthy infants
Infant formula
Prebiotics
Lead sponsor: PT. Sari Husada
Sponsor class: INDUSTRY
Collaborators: name: Danone Global Research & Innovation Center
First posted: 2012-01-24
Enrollment: 164
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference between beneficial bacteria I level in stool at week 4 and week 8.
timeFrame: Week 4, Week 8.
Secondary outcomes:
measure: Difference between beneficial bacteria II level in stool at week 4 and week 8.
timeFrame: Week 4, Week 8.
measure: Difference between pH of stool at week 4 and week 8.
timeFrame: Week 4, Week 8.
measure: Difference between stool consistency at week 4 and week 8.
timeFrame: Week 4, Week 8.
measure: Difference between sIgA at week 4 and week 8.
timeFrame: Week 4, Week 8.
measure: Difference between SCFA at week 4 and week 8.
timeFrame: Week 4, Week 8.
measure: Safety and tolerability.
timeFrame: From date of baseline visit (day 1) until the date of visit 8 (day 56)
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Research Unit of Indonesian Pediatrics Association
Study officials:
affiliation: Research Unit of Indonesian Pediatrics Association
name: Hanifah Oswari, dr., Sp.A(K), PhD
role: PRINCIPAL_INVESTIGATOR
References: