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

PT. Sari Husada1 site in 1 country164 target enrollmentOctober 2011

ConditionsHealthy Infants

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Healthy Infants
Sponsor: PT. Sari Husada
Enrollment: 164
Locations: 1
Primary Endpoint: Difference between beneficial bacteria I level in stool at week 4 and week 8.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

February 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

PT. Sari Husada

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Time Frame: Week 4, Week 8.

Secondary Outcomes

Difference between SCFA at week 4 and week 8.(Week 4, Week 8.)
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.)
Safety and tolerability.(From date of baseline visit (day 1) until the date of visit 8 (day 56))