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The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)

NCT02796872 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2017-07-19

No results posted yet for this study

Summary

This survey is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance, gut health, fecal flora and immune function.

Conditions

  • Dietary Modification

Interventions

DIETARY_SUPPLEMENT

GOS

GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)

DIETARY_SUPPLEMENT

B-GOS 3%

Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)

DIETARY_SUPPLEMENT

B-GOS 2%

Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)

DIETARY_SUPPLEMENT

Mother's breast milk

exclusively breastfed infants for at least 7 days prior to enrollment

Sponsors & Collaborators

  • Clasado

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Days
Max Age
18 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-12-31
Completion
2017-05-31

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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 NCT02796872 on ClinicalTrials.gov