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OpenTrials
Completed

NCT Number: NCT01515644

Study on the Effect of Inulin in Infant Formula on Gut Health

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.

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Key information

Conditions

Age range

3 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Unit of Indonesian Pediatrics Association

Jakarta, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Powder based infant formula

Other

Powder based infant formula with Inulin I

Primary outcomes

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

    Time frame: Week 4, Week 8.

Secondary outcomes

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

    Time frame: Week 4, Week 8.

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

    Time frame: Week 4, Week 8.

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

    Time frame: Week 4, Week 8.

  4. Difference between sIgA at week 4 and week 8.

    Time frame: Week 4, Week 8.

  5. Difference between SCFA at week 4 and week 8.

    Time frame: Week 4, Week 8.

  6. 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.

Sponsors and collaborators

Lead sponsor

PT. Sari Husada

Industry

Collaborators

  • Danone Global Research & Innovation Center

Registry information

Official study title

A Randomized, Double-blind, Controlled Study on the Effect of Inulin on Gut Health of Infants

Acronym: STAR-IFFO

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2012
Registry last updated
Apr 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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