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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dietary Modification

Intervention / Treatment
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* Dietary Supplement: GOS
* Dietary Supplement: B-GOS 3%
* Dietary Supplement: B-GOS 2%
* Dietary Supplement: Mother's breast milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Days
Maximum Age: 18 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: mother's breast milk.<br>mother's breast milk. | Dietary Supplement: Mother's breast milk<br>* exclusively breastfed infants for at least 7 days prior to enrollment<br>|
| Active Comparator: other GOS<br>Commercial infant formula containing 4% w/w FOS:GOS (1:3) | Dietary Supplement: GOS<br>* GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)<br>|
| Experimental: B-GOS 3%<br>Commercial infant formula containing 3% w/w FOS:B -GOS (1:2) | Dietary Supplement: B-GOS 3%<br>* Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)<br>|
| Experimental: B-GOS 2%<br>Commercial infant formula containing 4% w/w FOS:B -GOS (1:3) | Dietary Supplement: B-GOS 2%<br>* Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric parameters | body length, body weight, and head circumferences at enrollment (15± 3 days of age), 30, 60, 90, 120, 150 and 180 days of age | 6 months | 
| Fecal bacteria analysis | o Fecal bacteria analysis of Bifidobacterium, Lactobacillus, Clostridium perfringens and Escherichia coli at the enrollment 30 days of age ,120 days of age and 180 days of age | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary | tool characteristics, tolerance, formula acceptance, stress and 3-day well-being (quality of life) questionnaire prior to each survey visit recorded at 30, 60, 90, 120, 150 and 180 days of age | 6 months | 
| Formula intake | Formula intake (24-hour dietary recall) at 30, 60, 90, 120, 150 and 180 days of age | 6 months | 
| All medically confirmed adverse events and antibiotic record | All medically confirmed adverse events including crying, gaseous colics, regurgitation, vomit, skin rashes, fever and concomitant medications recorded on medical records as a measure of safety and tolerability throughout the survey period. | 6 months | 
| Fecal sIgA and SCFA analysis | Fecal sIgA and SCFA analysis at 30 days of age (visit 1) and 180 days of age (visit 6) | 6 months | 
| Saliva cortisol, IgA, chromogranin A and lysozyme | Saliva cortisol, IgA, chromogranin A and lysozyme at 30, 90 and 180 days of age | 6 months |