Dietary Modification
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGOS
GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)
DIETARY_SUPPLEMENTB-GOS 3%
Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)
DIETARY_SUPPLEMENTB-GOS 2%
Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)
DIETARY_SUPPLEMENTMother's breast milk
exclusively breastfed infants for at least 7 days prior to enrollment
Sponsors
Clasado
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Days to 18 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric parameters | 6 months | body length, body weight, and head circumferences at enrollment (15± 3 days of age), 30, 60, 90, 120, 150 and 180 days of age |
| Fecal bacteria analysis | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All medically confirmed adverse events and antibiotic record | 6 months | 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. |
| Dietary | 6 months | 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 |
| Saliva cortisol, IgA, chromogranin A and lysozyme | 6 months | Saliva cortisol, IgA, chromogranin A and lysozyme at 30, 90 and 180 days of age |
| Fecal sIgA and SCFA analysis | 6 months | Fecal sIgA and SCFA analysis at 30 days of age (visit 1) and 180 days of age (visit 6) |
| Formula intake | 6 months | Formula intake (24-hour dietary recall) at 30, 60, 90, 120, 150 and 180 days of age |
Outcome results
None listed