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

Clasado

Status: Completed

Conditions: Dietary Modification

Treatments: Dietary Supplement: GOS; Dietary Supplement: B-GOS 2%; Dietary Supplement: Mother's breast milk; Dietary Supplement: B-GOS 3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02796872

CLA12016CN

Details and patient eligibility

About

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.

Enrollment: 392 patients

Sex: All

Ages: 12 to 18 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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392 participants in 4 patient groups, including a placebo group

mother's breast milk.

Placebo Comparator group

Description:

mother's breast milk.

Treatment:

Dietary Supplement: Mother's breast milk

other GOS

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: GOS

B-GOS 3%

Experimental group

Description:

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

Treatment:

Dietary Supplement: B-GOS 3%

B-GOS 2%

Experimental group

Description:

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

Treatment:

Dietary Supplement: B-GOS 2%