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

April 22, 2013 updated by: PT. Sari Husada

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Research Unit of Indonesian Pediatrics Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 4 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 II
Intervention group II: Powder based Infant formula with Inulin II
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
PLACEBO_COMPARATOR: Intervention group III
Intervention group III: Powder based Infant formula without Inulin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between beneficial bacteria I level in stool at week 4 and week 8.
Time Frame: Week 4, Week 8.
Week 4, Week 8.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between beneficial bacteria II level in stool at week 4 and week 8.
Time Frame: Week 4, Week 8.
Week 4, Week 8.
Difference between pH of stool at week 4 and week 8.
Time Frame: Week 4, Week 8.
Week 4, Week 8.
Difference between stool consistency at week 4 and week 8.
Time Frame: Week 4, Week 8.
Week 4, Week 8.
Difference between sIgA at week 4 and week 8.
Time Frame: Week 4, Week 8.
Week 4, Week 8.
Difference between SCFA at week 4 and week 8.
Time Frame: Week 4, Week 8.
Week 4, Week 8.
Safety and tolerability.
Time Frame: From date of baseline visit (day 1) until the date of visit 8 (day 56)
The safety and tolerability achieved by continuous recording of adverse events, including the occurrence of diarrhea and constipation.
From date of baseline visit (day 1) until the date of visit 8 (day 56)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT. Sari Husada

Collaborators

Danone Research

Investigators

  • Principal Investigator: Hanifah Oswari, dr., Sp.A(K), PhD, Research Unit of Indonesian Pediatrics Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (ESTIMATE)

January 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 22, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CT.01.2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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