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

NCT01515644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2013-04-24

No results posted yet for this study

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.

Conditions

  • Healthy Infants

Interventions

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

Sponsors & Collaborators

  • Danone Global Research & Innovation Center

    collaborator INDUSTRY

  • PT. Sari Husada

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01515644 on ClinicalTrials.gov