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

Healthy Infants Clinical Trial

— STAR-IFFO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515644
• Other study ID #: CT.01.2010
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2012
• Last updated: April 22, 2013
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: PT. Sari Husada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 4 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Infants

Intervention

Other:
• Powder based infant formula
Powder based infant formula with Inulin I
• Powder based infant formula
Powder based infant formula with Inulin II
• Powder based infant formula
Powder based infant formula without Inulin

Locations

Country	Name	City	State
Indonesia	Research Unit of Indonesian Pediatrics Association	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
PT. Sari Husada	Danone Research

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between beneficial bacteria I level in stool at week 4 and week 8.		Week 4, Week 8.	No
Secondary	Difference between beneficial bacteria II level in stool at week 4 and week 8.		Week 4, Week 8.	No
Secondary	Difference between pH of stool at week 4 and week 8.		Week 4, Week 8.	No
Secondary	Difference between stool consistency at week 4 and week 8.		Week 4, Week 8.	No
Secondary	Difference between sIgA at week 4 and week 8.		Week 4, Week 8.	No
Secondary	Difference between SCFA at week 4 and week 8.		Week 4, Week 8.	No
Secondary	Safety and tolerability.	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)	Yes