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
  Purpose

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.


Condition Intervention Phase
Healthy Infants
Other: Powder based infant formula
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Controlled Study on the Effect of Inulin on Gut Health of Infants

Resource links provided by NLM:


Further study details as provided by PT. Sari Husada:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 164
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group I
Intervention group I: Powder based Infant formula with Inulin I
Other: Powder based infant formula
Powder based infant formula with Inulin I
Experimental: Intervention group II
Intervention group II: Powder based Infant formula with Inulin II
Other: Powder based infant formula
Powder based infant formula with Inulin II
Placebo Comparator: Intervention group III
Intervention group III: Powder based Infant formula without Inulin
Other: Powder based infant formula
Powder based infant formula without Inulin

  Eligibility

Ages Eligible for Study:   3 Months to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515644

Locations
Indonesia
Research Unit of Indonesian Pediatrics Association
Jakarta, Indonesia
Sponsors and Collaborators
PT. Sari Husada
Danone Research
Investigators
Principal Investigator: Hanifah Oswari, dr., Sp.A(K), PhD Research Unit of Indonesian Pediatrics Association
  More Information

No publications provided

Responsible Party: PT. Sari Husada
ClinicalTrials.gov Identifier: NCT01515644     History of Changes
Other Study ID Numbers: CT.01.2010
Study First Received: January 5, 2012
Last Updated: April 22, 2013
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by PT. Sari Husada:
Healthy infants
Infant formula
Prebiotics

ClinicalTrials.gov processed this record on July 22, 2014