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

NCT ID: NCT02796872

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

mother's breast milk.

mother's breast milk.

Group Type: PLACEBO_COMPARATOR

Mother's breast milk

Intervention Type: DIETARY_SUPPLEMENT

exclusively breastfed infants for at least 7 days prior to enrollment

other GOS

Commercial infant formula containing 4% w/w FOS:GOS (1:3)

Group Type: ACTIVE_COMPARATOR

GOS

Intervention Type: DIETARY_SUPPLEMENT

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

B-GOS 3%

Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)

Group Type: EXPERIMENTAL

B-GOS 3%

Intervention Type: DIETARY_SUPPLEMENT

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

B-GOS 2%

Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)

Group Type: EXPERIMENTAL

B-GOS 2%

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

GOS

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

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DIETARY_SUPPLEMENT

Mother's breast milk

exclusively breastfed infants for at least 7 days prior to enrollment

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• o 15 ± 3 days of age at randomization, inclusive (day of birth is considered day 0)

• Singleton birth
• Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
• Birth weight of 2500g to 4000g
• Signed informed consent obtained for infant's participation in the survey
• Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey
• APGAR score after 5 minutes of life > 7
• Consuming only one source of nutrition
• Formula-fed infant: Infant consuming infant formula as the sole source of nutrition for 7 consecutive days prior to randomization
• Breastfed infant: Infant consuming mother's breast milk as the sole source of nutrition for 7 consecutive days prior to registration

Exclusion Criteria

• Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days
• Diseases jeopardizing intrauterine growth
• Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
• Infant born from mother suffering from metabolic and/or chronic diseases
• Infant with an acute infection or gastroenteritis at time of randomization or registration
• Infant consuming supplemental foods
• Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake at time of randomization or registration
• Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others

• Minimum Eligible Age: 12 Days
• Maximum Eligible Age: 18 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clasado

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CLA12016CN

Identifier Type: -

Identifier Source: org_study_id