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

Phase 3

Completed

• Conditions: Healthy Infants
• Interventions: Other: Powder based infant formula

• Registration Number: NCT01515644
• Lead Sponsor: PT. Sari Husada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-24
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group I	Powder based infant formula	Intervention group I: Powder based Infant formula with Inulin I
Intervention group II	Powder based infant formula	Intervention group II: Powder based Infant formula with Inulin II
Intervention group III	Powder based infant formula	Intervention group III: Powder based Infant formula without Inulin

Primary Outcome Measures

Name	Time	Method
Difference between beneficial bacteria I level in stool at week 4 and week 8.	Week 4, Week 8.

Secondary Outcome Measures

Name	Time	Method
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.
Safety and tolerability.	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.

Trial Locations

Locations (1)

Research Unit of Indonesian Pediatrics Association; 🇮🇩 Jakarta, Indonesia