Study on the Effect of Inulin in Infant Formula on Gut Health (STAR-IFFO)

This study has been completed.
Sponsor:
Collaborator:
Danone Research
Information provided by (Responsible Party):
PT. Sari Husada
ClinicalTrials.gov Identifier:
NCT01515644
First received: January 5, 2012
Last updated: April 22, 2013
Last verified: April 2013

January 5, 2012
April 22, 2013
October 2011
February 2013   (final data collection date for primary outcome measure)
Difference between beneficial bacteria I level in stool at week 4 and week 8. [ Time Frame: Week 4, Week 8. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01515644 on ClinicalTrials.gov Archive Site
  • Difference between beneficial bacteria II level in stool at week 4 and week 8. [ Time Frame: Week 4, Week 8. ] [ Designated as safety issue: No ]
  • Difference between pH of stool at week 4 and week 8. [ Time Frame: Week 4, Week 8. ] [ Designated as safety issue: No ]
  • Difference between stool consistency at week 4 and week 8. [ Time Frame: Week 4, Week 8. ] [ Designated as safety issue: No ]
  • Difference between sIgA at week 4 and week 8. [ Time Frame: Week 4, Week 8. ] [ Designated as safety issue: No ]
  • Difference between SCFA at week 4 and week 8. [ Time Frame: Week 4, Week 8. ] [ Designated as safety issue: No ]
  • Safety and tolerability. [ Time Frame: From date of baseline visit (day 1) until the date of visit 8 (day 56) ] [ Designated as safety issue: Yes ]
    The safety and tolerability achieved by continuous recording of adverse events, including the occurrence of diarrhea and constipation.
Same as current
Not Provided
Not Provided
 
Study on the Effect of Inulin in Infant Formula on Gut Health
A Randomized, Double-blind, Controlled Study on the Effect of Inulin on Gut Health of Infants

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy Infants
  • Other: Powder based infant formula
    Powder based infant formula with Inulin I
  • Other: Powder based infant formula
    Powder based infant formula with Inulin II
  • Other: Powder based infant formula
    Powder based infant formula without Inulin
  • Experimental: Intervention group I
    Intervention group I: Powder based Infant formula with Inulin I
    Intervention: Other: Powder based infant formula
  • Experimental: Intervention group II
    Intervention group II: Powder based Infant formula with Inulin II
    Intervention: Other: Powder based infant formula
  • Placebo Comparator: Intervention group III
    Intervention group III: Powder based Infant formula without Inulin
    Intervention: Other: Powder based infant formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
164
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
3 Months to 4 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01515644
CT.01.2010
No
PT. Sari Husada
PT. Sari Husada
Danone Research
Principal Investigator: Hanifah Oswari, dr., Sp.A(K), PhD Research Unit of Indonesian Pediatrics Association
PT. Sari Husada
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP