NCT01515644

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

January 5, 2012

Last Update Submit

April 22, 2013

Conditions

Healthy Infants

Keywords

Healthy infantsInfant formulaPrebiotics

Outcome Measures

Primary Outcomes (1)

  • Difference between beneficial bacteria I level in stool at week 4 and week 8.

    Week 4, Week 8.

Secondary Outcomes (6)

  • Difference between beneficial bacteria II level in stool at week 4 and week 8.

    Week 4, Week 8.

  • Difference between pH of stool at week 4 and week 8.

    Week 4, Week 8.

  • Difference between stool consistency at week 4 and week 8.

    Week 4, Week 8.

  • Difference between sIgA at week 4 and week 8.

    Week 4, Week 8.

  • Difference between SCFA at week 4 and week 8.

    Week 4, Week 8.

  • +1 more secondary outcomes

Study Arms (3)

Intervention group I

EXPERIMENTAL

Intervention group I: Powder based Infant formula with Inulin I

Other: Powder based infant formula

Intervention group II

EXPERIMENTAL

Intervention group II: Powder based Infant formula with Inulin II

Other: Powder based infant formula

Intervention group III

PLACEBO COMPARATOR

Intervention group III: Powder based Infant formula without Inulin

Other: Powder based infant formula

Interventions

Powder based infant formulaOTHER

Powder based infant formula with Inulin I

Intervention group I

Eligibility Criteria

Age3 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Expected investigational product intake of min 500ml per day
  • Written informed consent from the parents

You may not qualify if:

  • 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.
  • Not consuming study product longer than 2 days consecutively
  • Intake of study product is less than 500ml per day for 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit of Indonesian Pediatrics Association

Jakarta, Indonesia

Location

Study Officials

  • Hanifah Oswari, dr., Sp.A(K), PhD

    Research Unit of Indonesian Pediatrics Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 24, 2012

Study Start

October 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations

ID(1)