Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mother's breast milk. | Placebo Comparator | mother's breast milk. |
|
| other GOS | Active Comparator | Commercial infant formula containing 4% w/w FOS:GOS (1:3) |
|
| B-GOS 3% | Experimental | Commercial infant formula containing 3% w/w FOS:B -GOS (1:2) |
|
| B-GOS 2% | Experimental | Commercial infant formula containing 4% w/w FOS:B -GOS (1:3) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GOS | Dietary Supplement | GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3) |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
o 15 ± 3 days of age at randomization, inclusive (day of birth is considered day 0)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| B-GOS 3% | 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% | Dietary Supplement | Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3) |
|
| Mother's breast milk | Dietary Supplement | exclusively breastfed infants for at least 7 days prior to enrollment |
|
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 |